(135 days)
No
The device description details a simple, electronically controlled pump delivering a set amount of air based on pre-set pressure and cycle time. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML. The performance studies focus on basic device functionality and safety, not AI/ML performance metrics.
Yes
The device is described as intended to "aid in the prevention of DVT", "enhance blood circulation", "diminish post-operative pain and swelling", "reduce wound healing time", and "aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs." These are all therapeutic applications.
No
Explanation: The device is intended for therapeutic purposes like preventing DVT, enhancing circulation, and reducing pain/swelling, not for diagnosing medical conditions.
No
The device description explicitly states it is an "intermittent pneumatic compression system" that uses an "electronically controlled pump delivering a set amount of air to the leg cuffs" and includes "Internal rechargeable batteries (Li ion)". This indicates the device is a hardware system with integrated software, not a software-only device. The software testing mentioned is for the software component of this hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for preventing DVT and treating various circulatory issues by stimulating blood flow in the extremities. This is a therapeutic and preventative function performed directly on the patient's body.
- Device Description: The description details an intermittent pneumatic compression system that applies pressure to the lower limbs. This is a physical intervention, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CIRCUL8 Luxe does not fit this description.
N/A
Intended Use / Indications for Use
CIRCUL8 Luxe, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used to:
- Aid in the prevention of DVT;
- Enhance blood circulation:
- Diminish post-operative pain and swelling:
- Reduce wound healing time;
- Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Product codes
JOW
Device Description
The CIRCUL8 Luxe DVT Prevention Device is an ambulatory, portable, light weight, prescriptive intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The purpose of the CIRCUL8 Luxe is to aid in the prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This is accomplished by an electronically controlled pump delivering a set amount of air to the leg cuffs that, in turn, compress the calf or calves to aid blood flow out of the lower extremities. The pump will inflate each leg cuff to a pre-set pressure of 60mmHg (± 5 mmHg) and deflate once the pressure is reached. The cycles are repeated on each unit until the power is turned off. Internal rechargeable batteries (Li ion) allow the CIRCUL8 Luxe to be completely portable, thus preventing interruptions in treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower limb(s) (Calf)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility.
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)
Non-Clinical Summary:
The results from nonclinical tests demonstrated that the proposed CIRCUL8 Luxe meets design, safety, and performance requirements; and does not raise any new concerns of safety and effectiveness.
- Testing Item: Biocompatibility
- Comments: CIRCUL8 Luxe device passed Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10) tests.
- Testing Item: Electromagnetic Compatibility and Electrical Safety
- Comments: CIRCUL8 Luxe passed - Electrical Safety (IEC 60601-1) - EMC (IEC 60601-1-2)
- Testing Item: Battery (Li-ion)
- Comments: Li-ion battery passed test requirements stated in IEC 62133-2
- Testing Item: Software
- Comments: Software verification and validation met software requirements specifications for moderate level of concern.
- Testing Item: Performance
- Comments: Device performance confirmed in bench testing for - Pressure delivery - average maximum pressure reached for the Circul8 Luxe was 62.03mmHg - Cycle time - average cycle time for the Circul8 Luxe device was 74.8 seconds - Leakage - average leakage test value for the Circul8 Luxe device was 58.2 - Burst - average burst pressure for Circul8 Luxe device was not less than 2x maximum operating pressure plus indicated tolerance.
Conclusion:
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to the legally marketed predicate device (K160318).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 8, 2021
Ortho8 Inc. % John Beasley Senior Consultant MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 89015
Re: K211235
Trade/Device Name: CIRCUL8 Luxe DVT Prevention Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 4, 2021 Received: August 9, 2021
Dear John Beasley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211235
Device Name
CIRCUL8 Luxe DVT Prevention Device
Indications for Use (Describe)
CIRCUL8 Luxe, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used to:
- · Aid in the prevention of DVT;
- · Enhance blood circulation:
- · Diminish post-operative pain and swelling:
- · Reduce wound healing time;
· Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
ORT
Ortho8, Inc.
2217 Plaza Drive
Rocklin, CA 95765
1-916-289-4002
| 510(k) Summary | Preparation Date: 07 Sep 2021 | |||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Ortho8, Inc. | |||
| Applicant Address | 2217 Plaza Drive, Rocklin, CA 95765 | |||
| Applicant Telephone Number | 1-916-289-4002 | |||
| Applicant Contact | Taylor Nordeen | |||
| Applicant Contact Email | taylor@pmpmed.com | |||
| Correspondent Name | MedTech Review, LLC | |||
| Correspondent Address | 257 Garnet Garden Street, Henderson, NV, 89015, US | |||
| Correspondent Telephone Number | 1-612-889-5168 | |||
| Correspondent Contact | Mr. John Beasley, RAC (US) | |||
| Correspondent Contact Email | john@medtechreview.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Circul8 Luxe DVT Prevention Device | |||
| Common Name | Intermittent Compression Sleeve | |||
| Classification Name | Sleeve, Limb, Compressible | |||
| Regulation Number | 870.5800 | |||
| Product Code | JOW | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate [510(k)] # | Predicate Trade Name | Product Code | ||
| K160318 | PlasmaFlow Vascular Therapy System | JOW | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The CIRCUL8 Luxe DVT Prevention Device is an ambulatory, portable, light weight, prescriptive intermittent |
pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The purpose of the CIRCUL8 Luxe is to aid in the prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This is accomplished by an electronically controlled pump delivering a set amount of air to the leg cuffs that, in turn, compress the calf or calves to aid blood flow out of the lower extremities. The pump will inflate each leg cuff to a pre-set pressure of 60mmHg (± 5 mmHg) and deflate once the pressure is reached. The cycles are repeated on each unit until the power is turned off. Internal rechargeable batteries (Li ion) allow the CIRCUL8 Luxe to be completely portable, thus preventing interruptions in treatment.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
CIRCUL8 Luxe, is intended to be an easy-to-use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used to:
- -Aid in the prevention of DVT;
- Enhance blood circulation; -
- Diminish post-operative pain and swelling; -
- Reduce wound healing time; -
- Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
4
TM Ortho8, Inc. ORT
2217 Plaza Drive Rocklin. CA 95765
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Indications for Use Comparison
21 CFR 807.92(a)(5)
Other than the difference in the name of the device, there are no differences in the indications for use of the subject device when compared to the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The CIRCUL8 Luxe DVT Prevention Device is substantially equivalent to the PlasmaFlow (predicate) device in function and operating principles to achieve identical results.
- CIRCUL8 Luxe system utilizes microprocessor-controlled pumps to deliver approximately 60mmHz of pressure air to bladders, using a cycle time of 60 seconds and pressure tolerance of 8%. Similarly, PlasmaFlow delivers 55mmHg and has 5% of pressure tolerance. The administered pressure and cvcle time on both devices deliver a safe amount of pressure over an acceptable period of time to be effective in DVT prevention.
- -Each cycle consists of inflation of the bladder, followed by a hold period and a rest period during which the bladder deflates, and the cuff relaxes.
- -The cuffs of both devices are comprised of single bladder PVC chambers encased in a covering of soft, non-latex, non-woven medical fabric for increased patient comfort and biocompatibility compliance.
- -Both devices use visual and audible alarms to indicate low battery error and pressure error. The CIRCUL8 Luxe also includes an adapter error alarm. Unattended alarms result in device shutdown, with CIRCUL& Luxe powering off after 30 seconds, giving sufficient time to become aware of a problem and taking action, and PlasmaFlow powering off after 10 seconds.
- The PlasmaFlow has two different modes: Mode 1 in which the pressure will inflate to 55mmHg and deflate; and Mode 2 in which the pressure will increase by 10mmHg increments until it reaches 55mmHg and then deflate in the same descending increments. CIRCUL8 Luxe has one fixed default operating mode, which operates the same as PlasmaFlow's Mode 1.
- Both devices use 3.7V Lithium-ion batteries in each cuff. -
- Verification testing included electrical safety, EMC, mechanical integrity, environmental and life cycle testing. Results demonstrate the CIRCUL8 Luxe has performance characteristics substantially equivalent to the predicate device.
5
Ortho8, Inc.
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | COMPARISON OF GENERAL INFORMATION / USES AND INDICATIONS | | |
| FDA Device
Description | Compressible Limb Sleeve, 21 CFR 870.5800 | Compressible Limb Sleeve, 21 CFR 870.5800 | Same. |
| FDA Product Code | JOW | JOW | Same. |
| Function | Aids venous return by using cyclic, intermittent,
pneumatic pressure application (inflation followed
by deflation) to compress the lower limb(s). | Aids venous return by using cyclic, intermittent,
pneumatic pressure application (inflation followed by
deflation) to compress the lower limb(s). | Same. |
| Intended Use | CIRCUL8 Luxe, is intended to be an easy-to-use
portable system, prescribed by a physician, for use
in the home or clinical setting to help prevent the
onset of DVT in patients by stimulating blood flow
in the extremities (simulating muscle contractions).
This device can be used to:
• Aid in the prevention of DVT;
• Enhance blood circulation;
• Diminish post-operative pain and swelling;
• Reduce wound healing time;
• Aid in the treatment and healing of: stasis
dermatitis, venous stasis ulcers, arterial and diabetic
leg ulcers, chronic venous insufficiency and
reduction of edema in the lower limbs.
The unit can also be used as an aid in the
prophylaxis for DVT by persons expecting to be
stationary for long periods of time. | The PlasmaFlow, model PF0001, is intended to be an
easy-to-use portable system, prescribed by a
physician, for use in the home or clinical setting to
help prevent the onset of DVT in patients by
stimulating blood flow in the extremities (simulating
muscle contractions). This device can be used to:
• Aid in the prevention of DVT;
• Enhance blood circulation;
• Diminish post-operative pain and swelling;
• Reduce wound healing time;
• Aid in the treatment and healing of: stasis
dermatitis, venous stasis ulcers, arterial and diabetic
leg ulcers, chronic venous insufficiency and reduction
of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis
for DVT by persons expecting to be stationary for
long periods of time. | Same. |
| Contraindication(s) | The Circul8 Luxe DVT Prevention Device must not
be used to treat the following conditions:
• Severe arteriosclerosis or other ischemic
vascular diseases | The PlasmaFlow must not be used to treat the
following conditions: Persons with suspected, active
or untreated: deep vein thrombosis, ischemic vascular
disease, severe arteriosclerosis, pulmonary edema,
severe congestive heart failure, thrombophlebitis or | Same. |
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
| | Acute or active deep vein thrombosis Existing pulmonary edema, pulmonary
embolisms, and/or congestive cardiac failure On patients with neuropathy, active
infections, and/or thrombophlebitis On extremities that are extremely
deformed, insensitive to pain, or where increased
venous or lymphatic return is undesirable Any local skin or tissue condition in which
the garments would interfere including but not
limited to: Vein ligation Recent skin graft Gangrene Dermatitis Open wounds Massive edema | an active infection;
On a leg where cuffs would interfere with the
following conditions: vein ligation, gangrene,
dermatitis, open wounds, a recent skin graft, massive
edema or extreme deformity of the leg; On patients
with neuropathy; On extremities that are insensitive
to pain; Where increased venous or lymphatic return
is undesirable | |
| Target Population /
Intended Users | Patients who need venous return. | Patients who need venous return. | Same. |
| Where Used | Home, Hospital, Surgery Center, Altitude travel,
areas of limited mobility. | Home, Hospital, Surgery Center, Altitude travel,
areas of limited mobility. | Same. |
| Application | Non-invasive / external | Non-invasive / external | Same. |
| Portability | Portable, ambulant | Portable, ambulant | Same. |
| Basis of operation | Aids venous return by using cyclic, intermittent,
pneumatic pressure application (inflation followed
by deflation) to compress the lower limb(s). | Aids venous return by using cyclic, intermittent,
pneumatic pressure application (inflation followed by
deflation) to compress the lower limb(s). | Same. |
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
| Anatomical Site /
Location of
treatment
application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Same. |
| System management | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Same. |
| Pressure Source | Micro pump controlled by electronic processor | Micro pump controlled by electronic processor | Same. |
| Operating Modes | Mode 1 | Mode 1 Mode 2 | Similar; predicate device
has a Mode 2. Mode 1 of
both devices have the same
functionalities. |
| Working Pressure | Mode one (default) is preset at 60 mmHg
Pressure tolerance ±5mmHG or ~8% | Mode one and Mode two are preset at 55 mmHg | Similar; Circul8 Luxe has a
tolerance of ±5mmHG
from 60mmHG which
equals 55mmHG to
65mmHG. The predicate's
working pressure falls
within the same range. |
| Cycle Time | 60 seconds | 60 seconds | Same. |
| System indicators | Battery: BLUE=On and fully
operational/RED=low voltage; connect charger
required.
Pressure: numerical pressure display mmHg. | Battery: BLUE=On and fully operational /
RED=low voltage; connect charger required.
Pressure: numerical pressure display mmHg. | Same. |
| System alarms | Low Battery Error: flashing red light + alarm
for 30 sec .; unit turns off.
Pressure Error: flashing red light + alarm for 30
sec .; unit turns off. | Battery Critical: RED=battery charge below
critical level; cycling stops; alarm sounds for 10
sec .; unit turns off.
Low Pressure or Leak: Flashing red/blue and
error code E1 displayed if pressure limit is not | Similar; appropriate alarms
to mitigate risks are
provided in both devices,
however different
terminology is used |
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
| - | Adapter Error: intermittent flashing red/blue
light +alarm for 5 sec; unit turns off. | reached within 30 sec. Cycling stops; alarm
sounds for 10 sec .; unit turns off. | (battery critical vs low
battery error). |
| System diagnostics | Visual indicators prompt recognitions of systems
faults | Audible and visual alarms prompt recognition of
system faults | Similar; both devices have
alarms. The execution
differs from audible and
visual by the predicate and
only visual for Circul8
Luxe. Patients are properly
warned with a visual
indicator that satisfies risk
mitigation. |
| Battery
Specifications | Rating Voltage: 7.4V Li-ion battery pack
rechargeable (one 3.7V Li-ion in each cuff) | Rating Voltage: 7.4V Li-ion battery pack
rechargeable (one 3.7V Li-ion in each cuff) | Same. |
| Internal
rechargeable
batteries | Yes | Yes | Same. |
| Air delivery from
pump to cuff
bladder | Via flexible plastic (PVC) tube(s) connected
directly to the air bladder. | Via flexible plastic (PVC) tube(s) connected directly
to the air bladder. | Same. |
| Sterility | Clean / non-sterile | Clean / non-sterile | Same. |
| Leg cuff usage | Single Patient Use | Single Patient Use | Same. |
| Material Used | Single bladder PVC chambers encased in a covering
of soft, non- latex, non-woven medical fabric (a
Polyester blend) or equivalent medical material for
increased patient comfort and biocompatibility
compliance. Grey colored, stitched, and thick. | Single bladder PVC chambers encased in a covering
of soft, non- latex, non-woven medical fabric (a
Polyester blend) or equivalent medical material for
increased patient comfort and biocompatibility
compliance. Grey colored, stitched, and thick. | Same. |
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
| | Material does not raise any question of safety or
effectiveness. | Material does not raise any question of safety or
effectiveness. | |
| | COMPARISON OF APPLICABLE STANDARDS | | |
| Biocompatibility: | Passed; biocompatible. | Passed or N/A | Similar; testing results and
facilities not
available for predicate but
standards for device are
similar and it is determined
predicate had same testing
standards; therefore,
substantially equivalent. |
| Software | Moderate | N/A | Similar; testing results and
facilities not
available for predicate but
standards for device are
similar and it is determined
predicate had same testing
standards; therefore,
substantially equivalent. |
| Electrical Safety and
EMC | Equivalent to predicate confirming with outside
testing results. Safety also confirmed in our risk
assessment and usability document. | Passed or N/A | Similar; testing results and
facilities not
available for predicate but
standards for device are
similar and it is determined
predicate had same testing
standards; therefore,
substantially equivalent. |
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
| Labeling,
Packaging, and
sterilization
Standards. | Substantial Equivalent | Substantial Equivalent | Similar; design of
documents and word
choice; does not pose a
danger to device safety or
effectiveness; therefore
substantially
equivalent. |
| TECHNICAL DATA | | | |
| Dimensions | 23.3" x 11.3" (59.3 x 28.7 cm) | 23" x 10.25" x 1.5" (58cm x 26cm x 4cm) | Similar; Circul8 Luxe is
0.3" wider and 1.05"
shorter in length compared
to the predicate, therefore
dimensions are similar. |
| Weight: Approx. | 0.66 lbs (0.3 kg) | 1.43 lb (.65 kg) | Similar; weight determined
differently - PlasmaFlow
weight pertains to both
units and the sleeves.
whereas, Circul8 Luxe
weighted only the main
control unit, weights are
similar. |
| Source of Power | Inner Battery (single cell, 3.7-volt Li-ion battery),
per cuff | Inner Battery (single cell, 3.7-volt Li-ion battery), per
cuff | Same |
| Power Supply
(Adapter) | Class II, input: 100 - 240Va.c., 50-60 Hz
output: 5Vd.c. @ 2A | Class II, input: 100 - 240Va.c., 50-60Hz output:
8.4Vd.c @ 1A | Similar; each device uses a
different charger with
different voltage capacity, |
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
| Temperature | System Operating Environment: 10°C (50°F) to
+35°C (95°F) | 10°C (50°F) to +40°C (104°F) | Similar; Circul8 Luxe has a
minor upper limit. |
| Humidity | Atmospheric: 45%-75%. Keep dry. | 30%-75%. Keep dry. | Similar; Circul8 Luxe
device has the lower limit
15% tighter. This does not
impact safety or
effectiveness. |
| Pressure Tolerances | Working Pressure: 8% | 5% | Similar; Circul8 Luxe
device claims to have a
wider percentage of
pressure tolerance. |
| Battery Charge | Approximately 6 hours | Approximately 4-5 hours | Similar; Circul8 Luxe does
not have a tolerance stated
on the battery charge
because the word
"Approximately" is stated. |
| Cleaning and
Disinfecting | Inspect the device and follow the cleaning and
disinfecting procedures prior to each use.
Clean the outer surface of the pump unit using a soft
cloth, moistened with 70% isopropyl alcohol. Air
dry only. Clean the exterior of the cuffs using a
damp cloth.
Unit must be completely dry prior to use. To ensure
that, leave the device in the OFF position and
disconnected from the wall outlet for at least 30
minutes (and as long as necessary for the unit to dry
completely) after cleaning or disinfecting. | Clean the outer surface of the pump unit using a soft
cloth, moistened with soapy water or 70% isopropyl
alcohol. Air dry only. Clean the exterior of the cuffs
using a soft cloth, moistened with soapy water or
70% isopropyl alcohol.
Unit must be completely dry prior to use. To ensure
that, leave the device in the OFF position and
disconnected from the wall outlet for at least 30
minutes (and if necessary, for the unit to dry
completely) after cleaning or disinfecting. Do not
remove the pump unit from the cuff. Do not place | Similar; both devices have
appropriate cleaning and
disinfection according to
device design. |
| Characteristics /
Features | CIRCUL8 Luxe
Subject Device | PlasmaFlow
Predicate Device (K160318) | Comments |
| | Do not remove the pump unit from the cuff. Do not
place cuffs in dryer or microwave. Do not use a hair
dryer to accelerate drying. Do not place the device
on top or in front of portable stationary radiators to
accelerate drying. Do not use water, abrasive
cleaners, oil, benzene gasoline and chemical agents
to wash the pump unit or the cuffs. Otherwise, the
life of the pump unit and cuffs will be shortened.
Do not wash the cuffs, rub with cloth gently. Do not
put the pump unit and cuffs near sharp things, such
as stoves, needles, scissors and so on. | cuffs in dryer or microwave. Do not use a hair dryer
to accelerate drying. Do not place the device on top
or in front of portable stationary radiators to
accelerate drying. Do not use abrasive cleaners. | |
| DISPOSAL | | | |
| Disposal | This unit is an electromechanical device that
includes printed circuit boards and rechargeable
batteries. Do not discard in landfill. Consult local
county requirements for proper disposal
instructions.
Pump control units contain rechargeable batteries.
Do not discard the pump unit in regular waste.
Bring the unit to your local recycling center or
contact Ortho8 Inc. | This unit is an electromechanical device that includes
printed circuit boards and rechargeable batteries. Do
not discard in landfill. Consult local county
requirements for proper disposal instructions. Pump
control units contain rechargeable batteries. Do not
discard the pump unit in regular waste.
Bring the unit to your local recycle center or contact
ManaMed. | Similar; both devices have
proper disposal instructions
in the IFU. |
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ORT
Rocklin. CA 95765 1-916-289-4002
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non-Clinical Summary:
The results from nonclinical tests demonstrated that the proposed CIRCUL8 Luxe meets design, safety, and performance requirements; and does not raise any new concerns of safety and effectiveness.
| Testing Item | Comments |
|---|---|
| Biocompatibility | CIRCUL8 Luxe device passed Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10) tests. |
| Electromagnetic | |
| Compatibility and | |
| Electrical Safety | CIRCUL8 Luxe passed |
- Electrical Safety (IEC 60601-1)
- EMC (IEC 60601-1-2) |
| Battery (Li-ion) | Li-ion battery passed test requirements stated in IEC 62133-2 |
| Software | Software verification and validation met software requirements specifications for moderate level of concern. |
| Performance | Device performance confirmed in bench testing for - Pressure delivery - average maximum pressure reached for the Circul8 Luxe was 62.03mmHg
- Cycle time - average cycle time for the Circul8 Luxe device was 74.8 seconds
- Leakage - average leakage test value for the Circul8 Luxe device was 58.2
- Burst - average burst pressure for Circul8 Luxe device was not less than 2x maximum operating pressure plus indicated tolerance. |
Conclusion:
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to the legally marketed predicate device (K160318).