(50 days)
No
The device description mentions microprocessor control and sensors for safety and functionality, but there is no mention of AI or ML algorithms for data analysis, decision-making, or adaptive therapy. The functions described are standard for controlled medical devices.
Yes
The device's intended uses and indications explicitly state the treatment of various medical conditions, reduction of edema, prevention of deep venous thrombosis (DVT), and healing of wounds, which are all therapeutic purposes.
No
The device is described as a treatment device that provides thermal control therapy and compression for various conditions like edema, lymphedema, and DVT prevention. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states it is comprised of a reusable pump and inflatable wraps, which are hardware components. The software controls these hardware components.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the NanoTherm and VascuTherm devices are used for external therapies involving thermal control (hot or cold) and compression applied to the extremities. They are treating conditions directly on the body, not analyzing samples taken from the body.
- Indications for Use: The indications listed are for treating conditions like vascular/lymphatic insufficiency, edema, soft tissue injuries, and preventing DVT. These are all conditions treated externally or through physical means, not through laboratory analysis of samples.
- Device Description: The description focuses on the physical components (pump, wraps), the mechanisms of action (thermal therapy, compression), and safety features. There is no mention of analyzing biological samples.
Therefore, the NanoTherm and VascuTherm devices fall under the category of therapeutic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
NanoTherm Indications:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
- Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
- Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
VascuTherm Indications:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
- Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
- Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
- Decrease the risk of deep venous thrombosis (DVT).
- Aids the blood flow back to the heart.
- Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
Product codes
JOW, ILO
Device Description
The NanoTherm and VascuTherm systems are new devices that are intended to function as intermittent, external pneumatic compression devices. The intended therapy of the NanoTherm device is to aid in the reduction and control of edema including lymphedema of the upper and lower extremities and venous stasis ulcers. The intended therapy of the VascuTherm device is to reduce the risk of the formation of deep venous thrombosis and to aid blood flow back to the heart via lower extremity limb compression, in addition to the intended uses of the NanoTherm device.
Physical Description: The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various single patient use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists of a reusable pump (VascuTherm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT.
Therapy Modality Used: The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the therapy site to reduce pain and swelling and compresses the limb using air to enhance fluid transfer and treatment of edema and lymphedema. The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps.
Safety Features: The NanoTherm and VascuTherm systems utilize microprocessor control with multiple sensors to ensure safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a possibly unsafe situation and to terminate therapy to prevent injury. All possible unsafe situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and lower extremities
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K942796, K981311, K023800, K043423, K011318, K964799
Reference Device(s)
K942796, K011318, K981311, K023800, K964799
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KC61866
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Section 5. 510(k) Summary
AUG 2 2 2006
APPLICANT [As Required by 21 CFR 807.92 a(1)]
Applicant:
Address:
Telephone Number:
ThermoTek, Inc.
1454 Halsey Way Carrollton, TX 75007
972-242-3232 972-446-1195 (fax)
Company Contact:
Tony Quisenberry President
June 21, 2006
Date:
DEVICE NAME [As Required by 21 CFR 807.92 a(2)]
Proprietary Name:
NanoTherm™ and VascuTherm™
Common Name:
Intermittent, External Pneumatic Compression Device
Classification Name:
Compressible Limb Sleeve (per 21 CFR section 870.5800)
IDENTIFICATION OF PREDICATE DEVICES
[As Required by 21 CFR 807.92 a(3)]
| • | Chattanooga Group, Inc. PresSsion S III | K942796 |
|---|---|---|
| • | KCI PlexiPulse® All-in-1 System | K981311 |
| • | Aircast VenaFlow System Disposable Cuffs | |
| as bundled | K023800 | |
| • | Bio Compression Systems BioComfort | |
| Garments | K043423 | |
| • | MicroTek Medical Holdings, Inc. | |
| Venodyne DVT Advantage Plus+ | K011318 | |
| • | Ormed Artrotherm Cryotherapy and | |
| Thermotherapy | K964799 sited and currently exempt | |
| Class II, per 21 CFR 890.5720 |
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DEVICE DESCRIPTION [As Required by 21 CFR 807.92 a(4)]
Intended Use
The NanoTherm and VascuTherm systems are new devices that are intended to function as intermittent, external pneumatic compression devices. The intended therapy of the niconfiteen, envice is to aid in the reduction and control of edema including lymphedema of the upper and lower extremities and venous stasis ulcers. The intended therapy of the or the upper and were is to reduce the risk of the formation of deep venous thrombosis new Yasour nen a blood flow back to the heart via lower extremity limb compression in addition to the intended uses of the NanoTherm device.
Physical Description
The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various The Nation use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists single patient use mixes of herm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT.
Therapy Modality Used
I herapy modality Oba
The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the The Nano Fierin and themity therapy site to reduce pain and swelling and compresses the writinou on an one on an enormance and fluid transfer and treatment of edema and lymphedema.
The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps.
Safety Features
Sancey Features
The NanoTherm and VascuTherm systems utilize microprocessor control with multiple r he Nano Filent and vansafety and system functionality, and to provide consistent and Sensors to choure panolalities. Alarms are both visual on the unit display and audible. repeatable therapy modentially unsafe situation and to terminate therapy to Alarms are in place to detect a possible in the situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B.
STATEMENT OF INTENDED USE [As Required by 21 CFR 807.92 a(5)]
Patient Population
The NanoTherm and VascuTherm devices` intended patient population is a non-ambulatory adult.
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NanoTherm Indications:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as o . I reatment of disorders associated with rabonial ess ulcers, post-mastectomy edema and chronic lymphedema.
- and chronic lymphedelha.
Reduction of edema associated with soft tissue injuries such as burns, postoperative ■ edema, and ligament sprains. - edema, and figallent splains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical в and/or surgical conditions.
NanoTherm Contraindications
- Presumptive evidence of congestive heart failure 트
- Presumptive evidence of congesting deep vein thrombosis or pulmonary embolism 트
- Suspected/observed deep acute venal thrombosis (phlebothrombosis) 트
- Suspected/observed inflammatory phlebitis process 트
- Suspected/observed pulmonary edema l
- Suspected/observed acute inflammations of the veins (thrombophlebitis) .
- Suspected/observed decompensated cardiac insufficiency 트
- Suspected/observed arterial dysregulation 트
- Suspected/observed erysipelas ■
- Suspected/observed carcinoma and carcinoma metastasis in the affected extremity 트
- Suspected/observed decompensated hypertonia 보
- Suspected/observed acute inflammatory skin diseases or infection 트
- Suspected/observed venous or arterial occlusive disease .
- Determine venous and lymphatic return is undesirable I
- Suspected/observed patient has Raynaud's Disease I
- Suspected/observed poor peripheral circulation b
- Suspected/observed hypersensitivity to cold I
- Patient therapy contact on extremity containing a fracture 트
- Extremities that are not sensitive to pain ■
VascuTherm Indications:
- nerm indications.
Treatment of disorders associated with vascular or lymphatic insufficiency such as ■ Treathent of disorders associated +1), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. - and chrome fymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains. - edema, and figativent sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical .. and/or surgical conditions. - Decrease the risk of deep venous thrombosis (DVT).
- Aids the blood flow back to the heart. .
- Alds the brood frow back to the neat:
Treat and assist healing of cutaneous ulceration (wounds), reduce would healing ■ Treat and assist healing of catalional (blood flow), reduce compartmental pressures, time, cimance arena (swelling), reduce the need for anticoagulant (blood thinning) medications.
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- Treat and assist healing of cutaneous ulceration (wounds), reduce would healing I time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
VascuTherm Contraindications
- Presumptive evidence of congestive heart failure 트
- Suspected/observed pre-existing deep vein thrombosis or pulmonary embolism 트
- Suspected/observed deep acute venal thrombosis (phlebothrombosis) 트
- Suspected/observed inflammatory phlebitis process 트
- Suspected/observed pulmonary edema 트
- Suspected/observed acute inflammations of the veins (thrombophlebitis) 트
- Suspected/observed decompensated cardiac insufficiency ■
- Suspected/observed arterial dysregulation 제
- Suspected/observed erysipelas 이
- Suspected/observed carcinoma and carcinoma metastasis in the affected extremity I
- Suspected/observed decompensated hypertonia 1
- Suspected/observed acute inflammatory skin diseases or infection 트
- Suspected/observed venous or arterial occlusive disease 제
- Determine venous and lymphatic return is undesirable 트
- Suspected/observed patient has Raynaud's Disease 미
- Suspected/observed poor peripheral circulation 트
- Suspected/observed hypersensitivity to cold 비
- Patient therapy contact on extremity containing a fracture 트
- Extremities that are not sensitive to pain I
The following patients must use the NanoTherm or VascuTherm therapy systems for t he forlowing ptact therapy under the supervision of a physician if they are:
- Individuals with extremities not sensitive to pain 메
- Individuals with extremely low blood pressure .
- Individuals with Raynaud's Disease I
- Hypersensitive to cold I
- Children
- l Diabetics
Differences in Indications
Dirrerences in manoTherm and VascuTherm devices are the same as those for the predicate devices listed in the Tables 1, 3 and 5 below.
4
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TECHNOLOGICAL CHARACTERISTICS [As Required by 21 CFR 807.92 a(6)]
The NanoTherm and VascuTherm devices have the same performance characteristics as the predicate devices.
The pneumatic control circuitry is a microprocessor-controlled system. Multiple safety The plicultiatio control one system including: high and low temperature alarms, alarms for unit malfunction situations, and system malfunction overpressure safety via a pressure vent switch. Power is supplied via 110 VAC line current.
vent Switch. I ower is supplied the 110 is received in cooling from 43°F to 49° and to 105°F in heating mode.
Comparison of features and principles of operation between the NanoTherm and Comparison of teatures and the predicate devices per Section 510(k) of the Act.
| Table 1. Summary of Edema/Lymphedema Therapy Modality Comparison for the Units | ||
|---|---|---|
| Parameter | NanoTherm and VascuTherm | |
| for edema/lymphedema only | Chatttanooga Group, Inc. | |
| PresSsion S III (K942796) | ||
| Pump Pressure Range | 30 mm Hg. ±5 mm Hg. | 30-100 mm Hg. ±5 mm Hg. |
| Default Pressure | 30 mm Hg. | User Selectable |
| Cycle Time | Inflation: 20 seconds | |
| Deflation: 40 seconds | Inflation: 5-120 seconds | |
| Deflation: 5-60 seconds | ||
| Indications for Use | Compression therapy is indicated for | |
| the following: | ||
| Treatment of disorders associated with | ||
| vascular or lymphatic insufficiency | ||
| such as Chronic Venous Insufficiency | ||
| (CVI), venous stasis ulcers, post- | ||
| mastectomy edema and chronic | ||
| lymphedema. | ||
| Reduction of edema associated with | ||
| soft tissue injuries such as burns, | ||
| postoperative edema, and ligament | ||
| sprains. (K942796) | Compression therapy is indicated for | |
| the following: | ||
| Treatment of disorders associated with | ||
| vascular or lymphatic insufficiency | ||
| such as Chronic Venous Insufficiency | ||
| (CVI), venous stasis ulcers, post- | ||
| mastectomy edema and chronic | ||
| lymphedema. | ||
| Reduction of edema associated with | ||
| soft tissue injuries such as burns, | ||
| postoperative edema, and ligament | ||
| sprains. | ||
| Decrease the risk of deep venous | ||
| thrombosis (DVT). | ||
| UL Mark | UL 60601 Class II, Type B | Class I, Type BF |
| CE Mark | IEC 60601-1 (safety) | |
| IEC 60601-1-1 (Emissions, Class A) | ||
| IEC 60601-1-2 (Immunity) | Not known |
na Therany Modality Comparison for the Units
f Edema/Lymphedema Biocompatibility Comparison for the Wraps
| Table 2. Summary of Edema/Lymphedema Biocompatibility Comparison | ||
|---|---|---|
| Parameter | Therapy wraps for | |
| edema/lymphedema only | BioCompression Systems, | |
| Inc. BioComfort Garments | ||
| (K043423) | ||
| Material in Skin Contact | 200 Denier Nylon Oxford | 200 Denier Nylon Oxford |
| Sterile/Non-Sterile | Sterile and Non-Sterile | Sterile and Non-Sterile |
| Single Patient Use | Yes | Yes |
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| Parameter | VascuTherm | Chatttanooga
Group, Inc.
PresSsion S III
(K942796) | MicroTek
Medical
Venodyne DVT
Advantage Plus+
(K011318) | KCI PlexiPulse All-in-1 System
(K981311) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pump
Pressure
Range | 45-100 mm Hg. ±5 mm
Hg. | 30-100 mm Hg. ±5 mm
Hg. (calf therapy only) | 40-45 mm Hg.
(calf and foot
therapy) | 140-180 mm Hg. ±5
mm Hg. (foot therapy
only) |
| Default
Pressure | 45 mm Hg. (calf)
100 mm Hg. (foot) | User Selectable | 45 mm Hg. | 160 mm Hg. (foot
therapy only) |
| Cycle Time | Inflation: 30 seconds
Deflation: 30 seconds | Inflation: 5-120
seconds
Deflation: 5-60 seconds | Inflation: 12 seconds
Deflation: 48
seconds | Inflation: 1-5 seconds
Deflation 20-60
seconds |
| Indications
for Use | Decrease the risk of deep
venous thrombosis, DVT.
(K942796, K011318,
K981311)
Aids the blood flow back
to the heart. (K011318)
Treat and assist healing of
cutaneous ulceration
(wounds), reduce would
healing time, enhance
arterial circulation (blood
flow), reduce
compartmental pressures,
reduce edema (swelling),
reduce the need for
anticoagulant (blood
thinning) medications.
(K981311) | Compression therapy is
indicated for the
following:
Treatment of disorders
associated with vascular
or lymphatic
insufficiency such as
Chronic Venous
Insufficiency (CVI),
venous stasis ulcers,
post-mastectomy edema
and chronic
lymphedema.
Reduction of edema
associated with soft
tissue injuries such as
burns, postoperative
edema, and ligament
sprains.
Decrease the risk of
deep venous thrombosis
(DVT). | The Venodyne DVT
Advantage model
620 is designed to
compress the lower
limbs aiding the
blood flow back
toward the heart to
prevent deep vein
thrombosis in
patients at risk. | The Cowboy XV is
intended for patients in
the home who would
benefit from increased
blood flow to:
Treat and assist healing
of cutaneous ulceration
(wounds), reduce would
healing time, enhance
arterial circulation
(blood flow), reduce
compartmental
pressures, reduce
edema (swelling),
reduce the need for
anticoagulant
medications
(medications that thin
the blood), and prevent
deep venous thrombosis
(DVT) (blood clots in
deep veins). |
| UL Mark | UL 60601 Class II, Type B | UL - Type BF, Class 1 | Not Known | UL |
| CE Mark | IEC 60601-1 (safety)
IEC 60601-1-1 (Emissions,
Class A)
IEC 60601-1-2 (Immunity) | Not Known | Yes | Not Known |
of DVT Therany Modality Comparison for the Unit ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
.
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| Table 4.Summary of DVT Biocom
Parameter | VascuTherm air-only
therapy wraps for DVT
prevention only | Aircast Vena Flow Sterile
Disposable Cuffs
(K023800) |
|--------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------|
| Material in Skin Contact | DuPont Softesse® Medical
Fabric (non-latex, non-woven) | DuPont Softesse® Medical
Fabric (non-latex, non-woven) |
| Sterile/Non-Sterile | Non-Sterile | Non-Sterile and Sterile |
| Single Patient Use | Yes | Yes |
of DVT Biocompatibility Comparison for the Wraps
Table 5. Summary of Water Circulating Thermal Therapy
| Parameter | NanoTherm and
VascuTherm devices | Artrotherm Cryotherapy and
Thermotherapy (K964799) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Therapy Type | Heat/Cool | Heat/Cool |
| Therapy Temperature Range | Heat: 105°F
Cold: 43°F to 49°F | Heat: 122°F
Cold: 43°F |
| Indications for Use | Localized thermal therapy (hot or
cold) for post traumatic and post
surgical medical and/or surgical
conditions. (K964799) | Localized thermal therapy (hot or
cold) for post traumatic and post
surgical medical and/or surgical
conditions. |
7
Image /page/7/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2006
ThermoTek, Inc. C/O Mr. Jay Kogoma Senior Staff Engineer 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087
Re: K061866
K061866
Trade/Device Name: NanoTherm and VascuTherm Systems
Trade/Device Name: Name 200 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW, ILO Dated: August 4, 2006 Received: August 7, 2006
Dear Mr. Kogoma:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 5 IQ(k) premium in enwivelst (for the indications
referenced above and have device is substantialy equivalent (for the indications referenced above and have determined the usevices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market predical Device America Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Fedical Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Fede devices that have been reclassified in accordance with the provisions of the Possion (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. T and Cosmetic Act (Act) that do not require approval or a picularios approvisions of the Act. The
You may, therefore, market the simply do recurements for annual registratio You may, therefore, market the Act include requirements for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements to: Michile of Groups of the adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nito either cities in especial estable on the line can
may be subject to such additional controls. Existing major regulations affect may be subject to such additional controls. EXSthig inajor regalitation and more of the may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In and be found in the Code of Federal Regulations, Title BT, Care of Federal Register.
publish further announcements concerning your device in the Federal Register.
8
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. vichner
Image /page/8/Picture/4 description: The image contains a handwritten symbol that appears to be a combination of curved and angular lines. The symbol is black and stands out against a white background. It is positioned on the left side of the image. The symbol is next to the letters 'E' and 'D'.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): _K061866
Device Name: NanoTherm________________________________________________________________________________________________________________________________________________________
Indications for Use:
- Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
- Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
- Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
-
Device Name: VascuTherm ______________________________________________________________________________________________________________________________________________________
Indications for Use: -
Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
-
Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
-
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
-
Decrease the risk of deep venous thrombosis (DVT).
Aids the blood flow back to the heart.
- Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
mountine of CDRH, Office of Device Evaluation (ODE) Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number. K061866