Comparison of Indications for Lower Extremity:
Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, post-bypass graft edema, post-operative edema secondary to venous ligation or venous stripping and edema secondary to sprains, strains and sports related injuries of the lower extremity.
Reduces chronic edema.
Assists in treating patients at risk for deep vein thrombosis (DVT) and pulmonary embolism (PE), including providing pre-, intra, and post-operative prophylaxis for DVT and PE.
Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease.
Assists healing of cutaneous ulcers.
Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery.
Treats venous stasis, venous insufficiency and varicose veins.
Reduces lymphedema, including lymphedema secondary to trauma and/or surgery and reduces or controls chronic lymphedema, including post-paralytic lymphedema due to stroke or spinal cord injury.

Comparison of Indications for Upper Extremity:
Reduces acute edema, such as elevated compartment pressures, edema secondary to trauma and/or surgical procedures, and edema secondary to sprains, strains and other sports related injuries of the upper extremity.
Reduces chronic edema.
Relieves circulatory disorders secondary to diminished blood flow, such as ischemia secondary to peripheral vascular disease.
Relieves pain, increases range of motion and limb mobility, and expedites return of function following trauma or surgery.
Reduces lymphedema, including lymphedema secondary to trauma and/or surgery, post-mastectomy lymphedema, and reduces or controls chronic lymphedema including post-paralytic lymphedema due to stroke or spinal cord injury.

Device Description

The A-V Impulse System Model 6060 (AVIS 6060) is designed to stimulate the natural pumping action of a patient's venous plexus system located in the sole of the foot. During the normal weightbearing phase of ambulation, blood is forcibly emptied from a plexus of veins in the sole of the foot into the deep and high pressure veins of the calf and thigh. This internal pump propels the blood up the leg and back to the heart. The A VIS 6060 foot pump mimics this natural physiological process for patients who are confined to the bed or are otherwise unable to walk normally due to trauma, surgery or pathology.

A similar pumping mechanism exists within the palm of the hand. There is a system of looping veins located near the metacarpo-phalangeal joints of the hand. Flexion of these joints triggers an internal pumping process that propels the blood into the deep and/or superficial veins of the arm and back to the heart. Besides flexing the fingers, increasing the tissue tension on the dorsum of the hand can trigger this pumping action. Either way, activation of the internal pump is followed by post-compression hyperaemia during which the venous plexus refills with blood.

AI/ML Overview

The provided text is a 510(k) summary for the A-V Impulse System Model 6060. It discusses the device's mechanism, safety features, and claims of effectiveness, referencing numerous clinical studies. However, it does not contain the specific information required to complete the requested table and answer all questions, particularly regarding detailed acceptance criteria, specific performance metrics of the device as a standalone entity, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC studies.

The document primarily focuses on presenting a summary of clinical literature to support expanded indications for use. It lists various conditions for which the device is claimed to be effective by citing existing studies. It does not present a single, structured study designed to establish acceptance criteria and demonstrate the device's performance against them in a systematic way that would allow direct population of the requested table.

Therefore, I can only extract limited information and point out what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the provided text does not define explicit "acceptance criteria" in a quantitative, measurable way that would typically be found in a study designed to demonstrate performance against pre-defined thresholds. Instead, it summarizes findings from various clinical studies, often stating "reduces swelling," "prevents need for surgery," "significantly decreases," "increases blood flow," etc. These are outcomes, but not framed as acceptance criteria with specific numerical targets.

Acceptance Criteria (Not explicitly stated as criteria, but inferred from indications and study outcomes)	Reported Device Performance (Summary of outcomes from cited literature)
Lower Extremities
Reduction of acute edema	"Reduces dangerously high compartment pressures" (Gardner et al., MacEachern et al.); "Statistically significant decrease in limb swelling" (Gardner et al., Stranks et al., Myerson & Henderson, Stockle et al., Beuker & Johnson, England & Simms)
Prevention/reduction of need for surgical intervention (e.g., fasciotomy)	"Prevented the need for surgical intervention in four patients" (Gardner et al.); "Prevented the need for fasciotomy" (MacEachern et al.)
Reduction of post-bypass graft edema	"Significant decrease in swelling" (England & Simms, White & Zarge); "Significantly diminished postoperative edema" (White & Zarge)
Reduction of post-operative edema secondary to venous ligation/stripping	"Well-suited for use in patients with post-operative edema and diminished venous capacity"
Reduction of edema secondary to sprains, strains, sports-related injuries	"Reduce edema following limb trauma in multiple studies" (including hip, knee injuries, ruptured ligaments, ankle sprains, various fractures)
Prophylaxis for DVT and PE	"Reduced the rate of fatal pulmonary embolisms (PE) from 9.1% to 0% and the six-month mortality from 18.2% to 6.3%" (randomized, prospective study, 92 patients); "No PEs occurred in the group treated with the AVIS 6060" vs. "six PEs occurring in the control group" (randomized prospective study, 74 patients); "Reduces the incidence of proximal DVTs"
Relief of ischemia secondary to peripheral vascular disease	"Significant relief" in ischemic rest pain (Gardner & Fox); "Successfully increased exercise tolerance" (Delis et al.); "Increases popliteal artery flow by 40-50%" (Nicolaides & Delis); "70% increases in waking distances" (3 months therapy, 10 patients); "Relieved ischemic rest pain significantly" (Morgan et al.); "Increase blood flow and relieve rest pain" (Morgan)
Improvement in Raynaud's Syndrome symptoms	"Increases arterial flow" in affected extremities; described as similar to medications for the disorder.
Improvement in Range of Motion and Limb Mobility	"Significant improvements in subtalar range of movement at three months, as well as an earlier return to work" (Erdmann et al. 23 patients); "Faster attainment of motion goals" (Beuker & Johnson)
Reduction of Reflex Sympathetic Dystrophy symptoms	"Reduced swelling and facilitated physiotherapy" (Gardner & Fox case studies)
Treatment of Varicose Veins / Venous Insufficiency	"Increased venous return" (McMullin et al.); "Effective in all types of venous insufficiency" (McMullin et al.); "Used successfully to treat varicose veins" (Beuker & Johnson)
Reduction of Lymphedema	"Effective in reducing accumulations of lymphedema" (Gardner & Fox); "Reduced the post-operative swelling"
Upper Extremities
Reduction of Compartment Syndrome	"Reduce compartmental pressure levels"; "Reduce both post-trauma edema and consequent venous congestion"
Reduction of acute edema secondary to trauma/surgery	"Swelling was reduced dramatically" (Reflex Sympathetic Dystrophy patients); "Significant reduction of swelling occurred within the first twenty-four hours in over fifty percent of the patients" (20 patients); "Significant decreases in post-traumatic edema" (7-10 days, 2 patients with radius fractures); "Dramatic reductions in swelling" (hand and arm injuries); "Average 52% reduction in swelling in four patients" (soft tissue injury)
Reduction of edema secondary to sprains, strains, sports-related injuries	"Effective in reducing post-traumatic edema"; "Reduce compartmental pressures" (e.g., frozen shoulder, tendinitis)
Relief of ischemia secondary to peripheral vascular disease	"Increase arterial blood flow" by impulse pumping; supported by lower extremity findings
Improvement in Raynaud's Syndrome symptoms	"Increases arterial blood flow" in hands and fingers; seen as consistent with medication effects
Improvement in Range of Motion and Limb Mobility	"Improved range of motion" (Stockle); "Faster attainment of motion goals"; "Average 52% reduction in swelling" (Kohrs); "Facilitated early use of the extremity"
Reduction of Reflex Sympathetic Dystrophy symptoms	"Useful to reduce swelling and facilitate physiotherapy" (Gardner & Fox case studies); "Reported success in treating" (Liedke, Stockle)
Reduction of Lymphedema	"Reduces lymphedema"; "Reduce lymphedema in patients following mastectomy"

2. Sample Size for Test Set and Data Provenance

Test Set Sample Sizes: Not explicitly defined as a single "test set." The device's effectiveness is supported by a collection of independent clinical studies, each with its own sample size. Examples mentioned:
- Compartment Syndrome: 11 patients (Gardner et al.), 1 case study (MacEachern et al.)
- Edema (Lower Extremities): 38 patients (Gardner et al.), 40 patients (Stockle et al.), 20 patients (England & Simms)
- DVT/PE: 92 patients (randomized, prospective, hip fractures), 74 patients (randomized, prospective, total hip replacement)
- Ischemia: 12 patients (Gardner & Fox), 10 patients (claudication), 10 patients (PVD), 22 patients (PVD)
- Range of Motion: 23 patients (Erdmann et al.)
- Edema (Upper Extremities): 20 patients, 2 patients (radius fractures), 4 patients (soft tissue injury)
Data Provenance: The studies cited are primarily clinical literature, implying real-world patient data. Given the context of a 510(k) submission, these would be retrospective summaries of previously published or conducted studies. The text does not specify the country of origin for each study, but the authors' names suggest a Western (likely UK/US) context. The studies are by nature prospective clinical studies conducted by various investigators, but the 510(k) itself is a retrospective compilation of their findings.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The text refers to "clinical investigators," "clinicians," and "authors" of medical literature. These would be expert physicians, but their specific qualifications for establishing 'ground truth' in the context of a defined test set (e.g., a consensus panel for image review) are not described. Each study would have its own methodology for diagnosis and outcome assessment, forming its "ground truth."

4. Adjudication Method for the Test Set

This information is not provided. As the content summarizes various independent clinical studies, there isn't a single, unified "adjudication method" for a single test set. Adjudication methods would have been specific to each cited study, but these details are not aggregated here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: The device (AVIS 6060) is a physical medical device (an impulse pump), not an AI algorithm for diagnostic reading. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device. The studies described compare device use versus non-use (control groups or baseline conditions) or report outcomes in device-treated patients.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Applicable, but definition differs: The AVIS 6060 is a standalone physical device designed to work independently after being applied to the patient. Its performance is entirely "standalone" in the sense that it mechanically performs its function without a human-in-the-loop directly influencing its immediate operation other than setup and monitoring. The effectiveness studies summarize its performance in this standalone capacity.

7. The type of ground truth used

The ground truth used in the various cited studies generally falls into these categories:

Clinical Outcomes/Measurements: Direct measurements of physiological parameters (e.g., compartment pressures, limb swelling/edema reduction, blood flow velocity/volume, popliteal artery flow, walking distances), incidence of medical events (PEs, DVTs), and subjective patient reports (pain relief, exercise tolerance, range of motion).
Pathology/Diagnosis: Implied by the conditions being treated (e.g., DVT, PE, various fractures, Raynaud's, PVD). The diagnosis of these conditions would also form part of the "ground truth" for patient inclusion in studies.
Expert Consensus (Implied): Clinical diagnosis and assessment of improvement by medical professionals (physicians, nurses, physiotherapists) involved in each study would constitute expert assessment/consensus on the patient's condition and treatment efficacy.

8. The Sample Size for the Training Set

Not Applicable: The AVIS 6060 is an electro-mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development. Its design is based on physiological principles, and its effectiveness validated through clinical studies on a "test set" (or multiple test sets, as seen here).

9. How the Ground Truth for the Training Set was Established

Not Applicable: As there is no "training set" for an AI algorithm, this question does not apply to the AVIS 6060 device.

Summary

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K964425

APPENDIX H

SUMMARY OF SAFETY AND EFFECTIVENESS

A. Safety

The AVIS 6060 is a non-invasive medical device that applies brief pressure pulses to the palm of the hand or sole of the foot. Rather than altering or manipulating normal body functions, the AVIS 6060 seeks to mimic the natural pumping mechanisms that already exist in the venous plexus systems in the foot and hand. Accordingly, the AVIS 6060 is intrinsically safe. Apart from the intrinsic safety of the physiological mechanism of the AVIS 6060, the product's components are designed to minimize potential risks to patients during product use. In particular, the product is equipped with the following safety features:

. In the event of power failure or malfunction of the AVIS 6060 generator, the venting valve automatically opens so that any pressure in the ImPad is released.
Audio and visual alarms are activated if ImPad pressure either exceeds or fails to achieve recommended levels. In the event of excess pressure, the unit automatically shuts down and can only be reactivated after the malfunction has been rectified and the unit reset. This feature protects the patient from potential problems relating to excess limb pressure. If the pressure is too low, the alarm sounds but the device continues to operate because this situation poses no threat to patient safety. The alarm merely

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signals to the operator that the product will not perform at normal effectiveness.

Relevant contraindications are printed in the product's instruction manual and brochure.
. Numerous warnings concerning proper use and maintenance of the AVIS 6060 are contained in the instruction manual, advertising brochure, and various labels affixed to the product. For example, users are advised to pay special attention to patients with poor circulation and fragile skin, and to use additional padding according to clinical judgment. A warning that the product is not explosion proof and must not be used in the presence of flammable anesthetics or other gases is also included.
. The product's labeling indicates that the device is restricted to sale by or on the order of a physician.
Software validation and other safety features.

In addition, the product has been independently tested for compliance with voluntary standards UL544-Standard for Medical and Dental Equipment (1994) and for compliance with electromagnetic compatibility standards. The AVIS 6060 successfully passed both tests.

Effectiveness B.

Set forth below is a brief summary of the clinical literature that supports the effectiveness of the AVIS 6060 for each of the clarified or new indications that Novamedix seeks to include in its labeling. In some cases, there are studies that directly support the proposed indication. For other claims, the support is more general in nature and based on established principles of medicine. Both kinds of support are described below. For convenience, the summaries are divided into two categories: lower extremity and upper extremity. A list of relevant clinical studies is included thereafter.

Lower Extremities

Compartment Syndrome: Clinical investigators have reported in the medical literature that the AVIS 6060 products reduce dangerously high compartment pressures. Gardner et al. studied the effects of the AVIS products on swelling and compartment pressures in eleven patients with tibial fractures. Of these eleven patients, the authors concluded that impulse pumping prevented the need for surgical intervention in four patients. MacEachern et al. documented a case study in which treatment
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with the AVIS 6060 prevented the need for fasciotomy to relieve Compartment Syndrome. Other clinicians have also reported that the AVIS system is effective in reducing compartmental pressures.

Edema Secondary to Trauma and/or Surgical Procedures: Gardner et al. found a statistically significant decrease in limb swelling (edema) in thirty eight patients following surgery or trauma to the lower extremity. In addition, Stranks et al. found that the AVIS 6060 provides a reduction in swelling in post-trauma patients undergoing hemiarthorplasty for displaced subcapital fractures of the femur. Myerson & Henderson also found that patients treated with the AVIS system, after trauma and surgery to the ankle, had a statistically significant reduction in swelling as compared to a control group. In a prospective study of forty patients, Stockle et al. found that impulse compression with the AVIS 6060 system resulted in significantly greater swelling reduction with respect to both post-traumatic (pre-operative) and post-operative treatment. Further, Beuker & Johnson found that treatment with the AVIS 6060 reduced swelling post-operatively following surgery for anterior cruciate ligament reconstruction, total hip arthroplasty and total knee arthroplasty. The England & Simms study of twenty patients found the use of the AVIS 6060 to decrease swelling in treated limbs post-operatively.
Post-Bypass Graft Edema: Following arterial revascularization grafting for ● the lower extremity, England and Simms found a significant decrease in swelling in limbs of patients treated with the AVIS 6060. Similarly, White and Zarge reported that the AVIS 6060 significantly diminished postoperative edema in patients following lower extremity revascularization procedures and resulted in a lower incidence of wound complications.
Post-Operative Edema Secondary to Venous Ligation or Venous Stripping: There is support for the conclusion that the AVIS 6060 is wellsuited for use in patients with post-operative edema and diminished venous capacity secondary to venous ligation or stripping. Immediate ambulation on post-operative day one is recommended after these procedures although this is not always possible. The AVIS 6060 mimics ambulation that triggers the pumping action for the same natural circulatory response that is associated with walking. The AVIS 6060 has also been shown to significantly increase venous blood flow in the lower extremity and has been effective with patients with diminished venous capacity.
Edema Secondary to Sprains, Strains and Sports Related Injuries: The A VIS 6060 has been shown to reduce edema following limb trauma in multiple studies, including studies that incorporated hip injuries, knee

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injuries, ruptured ligaments, ankle sprains, subtalar dislocations and dislocations of the ankle and foot. The device has also be found to provide significant reductions in post-traumatic edema in studies that included ankle fractures, calcaneal fractures, displace subcapital fractures of the neck and the femur, os calcis fractures, metatarsal fractures and tibial fractures.

Pulmonary Embolism; Pre-, Intra- and Post-operative Prophylaxis for . DVT and PE: Treatment with AVIS 6060 reduced the rate of fatal pulmonary embolisms (PE) from 9.1% to 0% and the six-month mortality from 18.2% to 6.3% in a randomized, prospective study involving ninetytwo patients following surgical repair of hip fractures. In another randomized prospective study involving seventy-four patients undergoing total hip replacement, no PEs occurred in the group treated with the AVIS 6060 in comparison to a six PEs occurring in the control group. Other studies show that the AVIS 6060 reduces the incidence of proximal DVTs which are often precursors of PE.
The Avis 6060 triggers the physiologic foot pump that is triggered during ambulation; as a result, the AVIS 6060 is ideal for patients who cannot ambulate before, during or after surgical procedures. The AVIS product has been used successfully pre-operatively, intra-operatively and postoperatively in the treatment of DVT and PE.
Ischemia Secondary to Peripheral Vascular Disease: Gardner & Fox ● report on a controlled trial involving twelve patients with ischemic rest pain secondary to arterial disease in which all pumped patients had significant relief. Delis et al. found that the AVIS 6060 successfully increased exercise tolerance in patients with stable claudication, which is a form of ischemia secondary to peripheral vascular disease. Consistent with these results, Nicolaides & Delis have reported that the AVIS 6060 increases popliteal artery flow by 40-50% in patients with intermittent claudication secondary to PVD. A study of ten patients with stable intermittent claudication revealed that three months of therapy with the AVIS 6060 resulted in 70% increases in waking distances. Further, Morgan et al. found that treatment with the AVIS 6060 relieved ischemic rest pain significantly in a study involving ten patients with PVD. Morgan concluded from this test and from a study involving twenty-two patients that "in ischemic limbs {impulse pumping] can increase blood flow and relieve rest pain and so is likely to limit tissue damage in patients awaiting surgery or when surgery has nothing to offer".
Raynaud's Syndrome: Raynaud's Syndrome is characterized by episodic . attacks of vasospasm that cause diminished arterial blood flow secondary to

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closure of the small arteries and arterioles of distal parts of the exterially in closure of the small arteries and afferiores of arterial flow, especially in
It is established that the AVIS 6060 increases arterial flow, especially in It is established that the AVIS 6000 increases andrial 100% of the AVIS 6060 results in
patients with dimission is the offered extremites much the same way the increase of blood flow in the affected extremities much the same way
the increase of blood flow in the affected extremints Syndrome treat the the increase of blood flow in the arrected extremation in the work.
that medications used to treat patients with Raynaud's Syndrome treat the disorder.

Range of Motion and Limb Mobility: In a study of twenty-three patients
in the many of the count of the found significant improvements in with os calcis fractures, Erdmann et al. found significant inprovements in . with os calcis fractures, Erdmann et al. Iount sperature period. The authors found significant improvements in the pumped group in subtalar range of movement at three months, as well as an earlier return to work. Beuker & Johnson, in their study of patients undergoing anterior cruciate
Beuker & Johnson, in their study of patients undersons and his arthroplasty. ligament reconstruction, total knee arthroplasty and hip arthroplasty, ligament reconstruction, what ance areatophing significantly less swelling
concluded that the AVIS treatment resulted in significantly less swelling
the concluded that the AV and, as a result, faster attainment of motion goals.
Reflex Sympathetic Dystrophy: Gardner & Fox presented four cases studies . Reflex Sympathetic Dystrophy: Garder of these cases suggested that use of the AVIS 6060 reduced swelling and facilitated physiotherapy which helped to
AVIS 6060 reduced swelling and facilitated physiotherapy is characterized by A VIS 6060 reduced swelling and tactions of RSD. RSD is characterized by decrease some of the characteristics of RSD. "ICB" is channel and the congestion, osteoporosis, and later relative ischaemia.
Varicose Veins: The vast majority of treatment regimens for varicose . veins involve treatments that increase venous resum. McMullin et al. veins involve treatments ular mercased venous return in patients with venous insufficiency. In addition, McMullin & al. noted that venous hypertension, insufficiency. In addition, Melvicons of varicose veins, occurs if either which correlates will with the symptems or incompetent. In the McMullin the muscle pump of 6060 was found to be effective in all types of venous insufficiency including deep, superficial and perforator incompetence. In a study conducted by Beuker & Johnson, the AVIS 6060 has been used successfully to treat varicose veins.
Lymphedema Secondary to Trauma and/or Surgery and Post-Paralytic ● Lymphedema: The AVIS 6060 treats lymphedema by increasing venous return. Lymph flow is known to increase as venous flow increases. Thus, because treatment with the AVIS 6060 significantly increases venous flow, the AVIS can be expected to remove excess lymphatic fluid from the limbs. Gardner & Fox found the AVIS 6060 effective in reducing accumulations of lymphedema in patients following femora-popliteal bypass

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grafting. Impulse compression reduced the post-operative swelling in these cases.

Upper Extremities

Compartment Syndrome: The objective in treating Compartment ● Companient Synarome: "The Occurio nation of fluid in the Limb Syndrome is to lower compartmental pressure. The AVIS 6060 has been compartment to lower compartmental pressure. Irevels which may allow
found generally to reduce compartmental pressure levels which may allow a patient to avoid surgical intervention through fasciotomy. Additionally, the AVIS 6060 has been found in the upper extremities to reduce both postthe AVIS 6060 has been found in the upper exceembiss are the elements of
trauma edema and consequent venous congestion which are the elements of trauma edema and collsequent venous congcential nerve and tissue damage and Compartmental Syndrome.
- Edema Secondary to Trauma and/or Surgical Procedures: Investigators ● Edema Secondary to Trummatic swelling secondary to arm injuries can be have reported that post-traditatic swenning seconding associated with patients with post-traumatic swelling of the upper extremity associated with Reflex Sympathetic Dystrophy, swelling was reduced dramatically by impulse compression therapy. Twenty patients were successfully treated implise compression therapy. I wellty pt. Significant reduction of swelling with the AVIS 0000 using a france mix as. See
  occurred within the first twenty-four hours in over fifty percent of the patients.

Additional clinical investigators have found that the AVIS 6060 reduces Auditional cinneal invost-surgical edema. Significant decreases in posttraumatic edema occurred following seven to ten days of treatment with the AVIS 6060 with a Hand ImPad in two patients with radius fractures. The A VIS 6060 also was used to treat post-traumatic injuries to the hand and arm, resulting in dramatic reductions in swelling. The AVIS 6060 was also used on ninety patients to treat soft tissue injury to the upper and lower extremities. The use of the hand pad impulse system resulted in an average 52% reduction in swelling in four patients.

Edema Secondary to Sprains, Strains and Sports Related Injuries: The ● A VIS 6060 is effective in reducing post-traumatic edema in the upper extremities, including edema associated with injuries with concomitant strains and/or sprains. The AVIS products also have been found to reduce compartmental pressures which can result in localized Compartment Syndrome such as frozen shoulder, supraspinatus tendinitis, tennis elbow and other tendon problems.

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Ischemia Secondary to Peripheral Vascular Disease: Ischemia secondary . to peripheral vascular disease ("PVD") results from decreased perfusion through the arteries supplying the extremities. The AVIS 6060 products increase arterial blood flow in the upper extremities by impulse pumping on the hand. In addition, the use of the AVIS in the upper extremity to treat PVD is further supported by the experiences using AVIS 6060 to treat PVD in the lower extremity.
Raynaud's Syndrome: There is clinical support for using the AVIS ● Raynaud's Syndrome. "IRaynaud's Syndrome. The AVIS 6060 increases products on patientin the upper extremities for patients with Raynaud's Syndrome, which is consistent with the use of a number of medications commonly used to "increase blood flow." Patients with Raynaud's Confinomy who have considerably decreased blood flow in their hands and Syndrome who have onehe AVIS products's ability to increase arterial blood flow.
Range of Motion and Limb Mobility: For the same underlying reasons ● that AVIS is effective in improving range of motion, limb mobility and that A VIS of other the lower extremity, AVIS is useful for these purposes in the upper extremity where the physiological effects of treatment with AVIS are identical. Use of the AVIS products also result in improved range of motion in patients with injury or trauma to the upper extremities. For example, Stockle reports that the range of motion was improved in patients treated with AVIS following radius fractures. The significant paticits transe with and edema secondary to treatment with AVIS 6060 in the upper extremities result in faster attainment of motion goals. Kohrs found that post-trauma use of the AVIS in the upper extremity resulted in an average 52% reduction in swelling and that the AVIS 6060 facilitated early use of the extremity.
Reflex Sympathetic Dystrophy: There are a number of case reports . involving the use of the AVIS 6060 to treat patients with Reflex Sympathetic Dystrophy. For example, Gardner & Fox present four case studies involving injuries to hands, each case suggesting that the product is useful to reduce swelling and facilitate physiotherapy. Additionally, Liedke has reported success in treating reflex sympathetic dystrophy in the upper extremity, and Stockle has reported similar clinical success using the alternative term "algodystrophy."
Lymphedema Secondary to Trauma and/or Surgery, Post-Mastectomy ● Lymphedema, and Post-Paralytic Lymphedema: The AVIS 6060 treats lymphedema by increasing venous return. Lymph flow is known to

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increase when venous flow increases. The AVIS 6060 removes excess
t the country of the country and sutremities by increasing venous flow in increase when venous flow increases. The AVIS oous temoves flow in the arms.

AVIS 6060 has also been found to reduce lymphedema in patients A VIS 6060 has also been found to realice tymphonuse the underlying following temore would of AVIS system is identical in the upper and best physiological effects of the AVIS system is identical in the upper extremity
extremities, the ability of AVIS to treat lymphedema in the upper extremity
of the ability of AVI can be explained similarly.

Relevant Clinical Literature

Abu-Owen, "Effects of Intermittent Pneumatic Compression of the Foot on the Foot on the Abu-Owen, "Effects of Intermittent Pheumane Compression of also of Vascular Surgery, (1993).

Andrews, B., Sommerville, K., Austin, S., Wilson, N., Browse, N.I., "Effect of Foot
Ford For Sommerced Valume of Valume of Blood Flow in the Deep Veins", British of Andrews, B., Sommerville, K., Austin, S., Wilson, IV., Drows, Ther,
Compression on the Velocity and Volume of Blood Flow in the Deep Veins", British of
Compression on the Vel Compresson, Vol. 80, February, 1993.

A.N.M. Gardener, R.H.Fox, Syndrome, The Return of Blood to the Heart, John Libby B.
The Heart, R.H.Fox, Syndrome, 1992 A.N.M. Gardon, England, 1993.

Beuker, J.T., Johnson, G., "The Arterial-Venous Foot Pump: A Preliminary Report."

Bourne, R.B., Rorabeck, C.H., "Compartment Syndrome of the Lower Leg" Clinical
Systems of the Same of D. L.H., "Company, I.D., Limincott Company, No. 240. Bourne, R.B., Roraberk, C.H., Comparanent Cyclesion.
Orthopaedics and Related Research, J.B. Lippincott Company, No. 240.

Bradley, J.G., Kruegner, G.H., Jager, H.J., "The Effectiveness of Intermittent Plantar Bradley, J.G., Kruegeer, G.H., Jager, T.H., J.R.P. Thrombosis After Total Hip
Venous Compression in Prevention of Deep Venous Thrombosis After Total Hip
1997 Venous Compressi Venous Compression in and of Arthroplasty, 8:57 (1993).

Cheatle, T.R., McMullin, G., and Schurr, J.H., "Deep Vein Reflux is Reduced by Cheatle, T.R., McMullin, G., and Schurt, 7.11., "Doop" (21 Sureery, 77:1424 (1990).
Compression of the Venous Foot Pump," British Journal of Surgery, 77:1424 (1990).

Clinical Practice of Sports Injury Prevention and Care, Renstrom, P.A.F.H. et al., Editors, Blackwell Scientific Publications, London, England.

Coffman, J.D., Cohen, A.S., "Total and Capillary Fingertip Blood Flow in Raynaud's Phenomenon, " New England Journal of Medicine, 285:259 (1971).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Novamedix Services Limited C/0 Mr. William H.E. von Oehsen Powell, Goldstein, Frazer & Murphy 1001 Pennsylvania Avenue, N.W. Sixth Floor - - - - - - - - -- Washington, D.C. 20004

JUL 28 1997

K964425 Re: R364423
A-V Impulse System Model 6060 Expanded Indications for Foot and Hand Regulatory Class: II (Two) Product Code: 74 (JOW) Dated: April 28, 1997 Received: April 29, 1997

Dear Mr. von Oehsen:

We have reviewed your Section 510(k) notification of intent to market we have reviewed your beceion one have determined the device is the device fererenced above and substantially equivalence (in interstate commerce prior to enclosure) to devices markedout of the Medical Device America May 26, 1970, cho been reclassified in accordance with the Co devices chat the Federal Food, Drug, and Cosmetic Act (Act), You may, therefore, market the device, subject to the general controls may, chererore, mannot on the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements requlatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. William H.E. von Oehsen

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K964425/5'
Device Name: A-V Impulse System Model for Go

Indications For Use:

Comparison of Indications for Lower Extremity
Approved Indication	Proposed Clarification or Expansion
Acute edema	Reduces acute edema, such as elevatedcompartment pressures, edema secondary totrauma and/or surgical procedures, post-bypass graft edema, post-operative edemasecondary to venous ligation or venousstripping and edema secondary to sprains,strains and sports related injuries of thelower extremity.
Chronic edema	Reduces chronic edema.
Deep vein thrombosis prophylaxis	Assists in treating patients at risk for deepvein thrombosis (DVT) and pulmonaryembolism (PE), including providing pre-,intra, and post-operative prophylaxis forDVT and PE.
Circulation enhancement	Relieves circulatory disorders secondary todiminished blood flow, such as ischemiasecondary to peripheral vascular disease.
Leg ulcers	Assists healing of cutaneous ulcers.
Leg pain incident to trauma orsurgery	Relieves pain, increases range of motionand limb mobility, and expedites return offunction following trauma or surgery.
us stasis/venous insufficiency	Treats venous stasis, venous insufficiencyand varicose veins.Reduces lymphedema, includinglymphedema secondary to trauma and/orsurgery and reduces or controls chroniclymphedema, including post-paralyticlymphedema due to stroke or spinal cord

Comparison of Indications for Upper Extremity
Approved Indication	Proposed Clarification or Expansion
Acute edema	Reduces acute edema, such as elevatedcompartment pressures, edema secondaryto trauma and/or surgical procedures, andedema secondary to sprains, strains andother sports related injuries of the upperextremity.
Chronic edema	Reduces chronic edema.
Circulation enhancement	Relieves circulatory disorders secondary todiminished blood flow, such as ischemiasecondary to peripheral vascular disease.
Pain	Relieves pain, increases range of motionand limb mobility, and expedites return offunction following trauma or surgery.
	Reduces lymphedema, includinglymphedema secondary to trauma and/orsurgery, post-mastectomy lymphedema,and reduces or controls chroniclymphedema including post-paralyticlymphedema due to stroke or spinal cordinjury.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Ruzic

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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(Optional Format 1-2-96)

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).