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.

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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the CIRCUL8 Luxe DVT Prevention Device. This regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with extensive acceptance criteria for complex AI algorithms.

Therefore, many of the typical acceptance criteria and study elements associated with AI/ML-driven medical devices (like MRMC studies, expert adjudication for ground truth of an AI, or large sample sizes for AI training/test sets) are not applicable to this traditional medical device submission. The device is a pneumatic compression system, not an AI/ML diagnostic or prognostic tool.

However, I can extract the available information related to performance testing and acceptance criteria as presented in the document based on the device's function.

CIRCUL8 Luxe DVT Prevention Device: Acceptance Criteria and Performance (Non-AI Device)

This document describes a traditional medical device (a pneumatic compression system) and its substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely related to engineering specifications and safety/performance benchmarks for a physical device, not AI model performance metrics. The "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Bench Testing)	Reported Device Performance
Biocompatibility	Passed Cytotoxicity (ISO 10993-5), Sensitization and Irritation (ISO 10993-10) tests.
Electrical Safety	Passed IEC 60601-1.
Electromagnetic Compatibility (EMC)	Passed IEC 60601-1-2.
Battery Performance (Li-ion)	Passed test requirements stated in IEC 62133-2.
Software Verification & Validation	Met software requirements specifications for moderate level of concern.
Pressure Delivery	Average maximum pressure reached was 62.03 mmHg. (Target pressure is 60mmHg ± 5 mmHg)
Cycle Time	Average cycle time was 74.8 seconds. (Target cycle time is 60 seconds)
Leakage	Average leakage test value was 58.2. (No unit provided, context suggests a measure of air retention or pressure loss)
Burst Pressure	Average burst pressure was not less than 2x maximum operating pressure plus indicated tolerance.

Note on Differences to Predicate:
The document also compares the CIRCUL8 Luxe's technical specifications to its predicate device (PlasmaFlow Vascular Therapy System) and notes the following "similarities" which can be interpreted as demonstrating acceptable performance relative to the predicate:

Operating Pressure: CIRCUL8 Luxe: 60 mmHg (±5mmHg or ~8%); Predicate: 55 mmHg. Comment: "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." This implies the predicate's 55mmHg falls within the acceptable range of the subject device's operation.
Cycle Time: Both 60 seconds. Comment: "Same."
System Alarms/Indicators: Both have alarms for low battery and pressure errors. CIRCUL8 Luxe's alarms cause shutoff after 30 seconds, Predicate's after 10 seconds. CIRCUL8 Luxe also has an "Adapter Error." Comment: "Similar; appropriate alarms to mitigate risks are provided in both devices, however different terminology is used (battery critical vs low battery error)."
Physical Dimensions/Weight: Are considered "similar" despite slight numerical differences, not impacting safety or effectiveness.
Power Supply: Different chargers with different voltage capacity, but considered "similar".
Temperature & Humidity Operating Environment: Considered "similar" despite minor differences in specified ranges.
Pressure Tolerances: CIRCUL8 Luxe has 8%, Predicate has 5%. Comment: "Similar; Circul8 Luxe device claims to have a wider percentage of pressure tolerance."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of units or cycles tested for each non-clinical bench test. It reports "average maximum pressure," "average cycle time," "average leakage test value," and "average burst pressure," implying that multiple measurements were taken on one or more devices.
Data Provenance: The data originates from non-clinical bench testing conducted by the device manufacturer (Ortho8 Inc.). The tests were performed to confirm that the device meets design, safety, and performance requirements and does not raise new concerns about safety and effectiveness.

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

Not Applicable. This is a traditional medical device, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for the device's performance is adherence to engineering specifications and international standards, measured directly by laboratory equipment during bench testing.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical bench testing of a physical device against engineering specifications, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a physical medical device, not a diagnostic AI intended to assist human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

Not Applicable. This device does not feature a standalone algorithm in the typical sense of AI/ML performance. Its "performance" is its mechanical function (delivering pressure for DVT prevention).

7. Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:
- Engineering Specifications: Pre-defined pressure levels, cycle times, alarm responses, etc.
- International Standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), ISO 10993-5/10 (Biocompatibility), IEC 62133-2 (Li-ion battery).
- Comparison to Predicate Device: Demonstrating similar performance characteristics to a legally marketed device.

8. Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

Not Applicable. There is no "training set" for this traditional medical device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K211235

Device Name

CIRCUL8 Luxe DVT Prevention Device

Indications for Use (Describe)

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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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.

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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.

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Ortho8, Inc.

Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate Device (K160318)	Comments
	COMPARISON OF GENERAL INFORMATION / USES AND INDICATIONS
FDA DeviceDescription	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 followedby deflation) to compress the lower limb(s).	Aids venous return by using cyclic, intermittent,pneumatic pressure application (inflation followed bydeflation) to compress the lower limb(s).	Same.
Intended Use	CIRCUL8 Luxe, is intended to be an easy-to-useportable system, prescribed by a physician, for usein the home or clinical setting to help prevent theonset of DVT in patients by stimulating blood flowin 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: stasisdermatitis, venous stasis ulcers, arterial and diabeticleg ulcers, chronic venous insufficiency andreduction of edema in the lower limbs.The unit can also be used as an aid in theprophylaxis for DVT by persons expecting to bestationary for long periods of time.	The PlasmaFlow, model PF0001, is intended to be aneasy-to-use portable system, prescribed by aphysician, for use in the home or clinical setting tohelp prevent the onset of DVT in patients bystimulating blood flow in the extremities (simulatingmuscle 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: stasisdermatitis, venous stasis ulcers, arterial and diabeticleg ulcers, chronic venous insufficiency and reductionof edema in the lower limbs.The unit can also be used as an aid in the prophylaxisfor DVT by persons expecting to be stationary forlong periods of time.	Same.
Contraindication(s)	The Circul8 Luxe DVT Prevention Device must notbe used to treat the following conditions:• Severe arteriosclerosis or other ischemicvascular diseases	The PlasmaFlow must not be used to treat thefollowing conditions: Persons with suspected, activeor untreated: deep vein thrombosis, ischemic vasculardisease, severe arteriosclerosis, pulmonary edema,severe congestive heart failure, thrombophlebitis or	Same.
Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate Device (K160318)	Comments
	Acute or active deep vein thrombosis Existing pulmonary edema, pulmonaryembolisms, and/or congestive cardiac failure On patients with neuropathy, activeinfections, and/or thrombophlebitis On extremities that are extremelydeformed, insensitive to pain, or where increasedvenous or lymphatic return is undesirable Any local skin or tissue condition in whichthe garments would interfere including but notlimited to: Vein ligation Recent skin graft Gangrene Dermatitis Open wounds Massive edema	an active infection;On a leg where cuffs would interfere with thefollowing conditions: vein ligation, gangrene,dermatitis, open wounds, a recent skin graft, massiveedema or extreme deformity of the leg; On patientswith neuropathy; On extremities that are insensitiveto pain; Where increased venous or lymphatic returnis 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 followedby deflation) to compress the lower limb(s).	Aids venous return by using cyclic, intermittent,pneumatic pressure application (inflation followed bydeflation) to compress the lower limb(s).	Same.
Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate Device (K160318)	Comments
Anatomical Site /Location oftreatmentapplication	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 devicehas a Mode 2. Mode 1 ofboth devices have the samefunctionalities.
Working Pressure	Mode one (default) is preset at 60 mmHgPressure tolerance ±5mmHG or ~8%	Mode one and Mode two are preset at 55 mmHg	Similar; Circul8 Luxe has atolerance of ±5mmHGfrom 60mmHG whichequals 55mmHG to65mmHG. The predicate'sworking pressure fallswithin the same range.
Cycle Time	60 seconds	60 seconds	Same.
System indicators	Battery: BLUE=On and fullyoperational/RED=low voltage; connect chargerrequired.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 30sec .; unit turns off.	Battery Critical: RED=battery charge belowcritical level; cycling stops; alarm sounds for 10sec .; unit turns off.Low Pressure or Leak: Flashing red/blue anderror code E1 displayed if pressure limit is not	Similar; appropriate alarmsto mitigate risks areprovided in both devices,however differentterminology is used
Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate Device (K160318)	Comments
-	Adapter Error: intermittent flashing red/bluelight +alarm for 5 sec; unit turns off.	reached within 30 sec. Cycling stops; alarmsounds for 10 sec .; unit turns off.	(battery critical vs lowbattery error).
System diagnostics	Visual indicators prompt recognitions of systemsfaults	Audible and visual alarms prompt recognition ofsystem faults	Similar; both devices havealarms. The executiondiffers from audible andvisual by the predicate andonly visual for Circul8Luxe. Patients are properlywarned with a visualindicator that satisfies riskmitigation.
BatterySpecifications	Rating Voltage: 7.4V Li-ion battery packrechargeable (one 3.7V Li-ion in each cuff)	Rating Voltage: 7.4V Li-ion battery packrechargeable (one 3.7V Li-ion in each cuff)	Same.
Internalrechargeablebatteries	Yes	Yes	Same.
Air delivery frompump to cuffbladder	Via flexible plastic (PVC) tube(s) connecteddirectly to the air bladder.	Via flexible plastic (PVC) tube(s) connected directlyto 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 coveringof soft, non- latex, non-woven medical fabric (aPolyester blend) or equivalent medical material forincreased patient comfort and biocompatibilitycompliance. Grey colored, stitched, and thick.	Single bladder PVC chambers encased in a coveringof soft, non- latex, non-woven medical fabric (aPolyester blend) or equivalent medical material forincreased patient comfort and biocompatibilitycompliance. Grey colored, stitched, and thick.	Same.
Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate Device (K160318)	Comments
	Material does not raise any question of safety oreffectiveness.	Material does not raise any question of safety oreffectiveness.
	COMPARISON OF APPLICABLE STANDARDS
Biocompatibility:	Passed; biocompatible.	Passed or N/A	Similar; testing results andfacilities notavailable for predicate butstandards for device aresimilar and it is determinedpredicate had same testingstandards; therefore,substantially equivalent.
Software	Moderate	N/A	Similar; testing results andfacilities notavailable for predicate butstandards for device aresimilar and it is determinedpredicate had same testingstandards; therefore,substantially equivalent.
Electrical Safety andEMC	Equivalent to predicate confirming with outsidetesting results. Safety also confirmed in our riskassessment and usability document.	Passed or N/A	Similar; testing results andfacilities notavailable for predicate butstandards for device aresimilar and it is determinedpredicate had same testingstandards; therefore,substantially equivalent.
Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate Device (K160318)	Comments
Labeling,Packaging, andsterilizationStandards.	Substantial Equivalent	Substantial Equivalent	Similar; design ofdocuments and wordchoice; does not pose adanger to device safety oreffectiveness; thereforesubstantiallyequivalent.
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 is0.3" wider and 1.05"shorter in length comparedto the predicate, thereforedimensions are similar.
Weight: Approx.	0.66 lbs (0.3 kg)	1.43 lb (.65 kg)	Similar; weight determineddifferently - PlasmaFlowweight pertains to bothunits and the sleeves.whereas, Circul8 Luxeweighted only the maincontrol unit, weights aresimilar.
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), percuff	Same
Power Supply(Adapter)	Class II, input: 100 - 240Va.c., 50-60 Hzoutput: 5Vd.c. @ 2A	Class II, input: 100 - 240Va.c., 50-60Hz output:8.4Vd.c @ 1A	Similar; each device uses adifferent charger withdifferent voltage capacity,
Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate 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 aminor upper limit.
Humidity	Atmospheric: 45%-75%. Keep dry.	30%-75%. Keep dry.	Similar; Circul8 Luxedevice has the lower limit15% tighter. This does notimpact safety oreffectiveness.
Pressure Tolerances	Working Pressure: 8%	5%	Similar; Circul8 Luxedevice claims to have awider percentage ofpressure tolerance.
Battery Charge	Approximately 6 hours	Approximately 4-5 hours	Similar; Circul8 Luxe doesnot have a tolerance statedon the battery chargebecause the word"Approximately" is stated.
Cleaning andDisinfecting	Inspect the device and follow the cleaning anddisinfecting procedures prior to each use.Clean the outer surface of the pump unit using a softcloth, moistened with 70% isopropyl alcohol. Airdry only. Clean the exterior of the cuffs using adamp cloth.Unit must be completely dry prior to use. To ensurethat, leave the device in the OFF position anddisconnected from the wall outlet for at least 30minutes (and as long as necessary for the unit to drycompletely) after cleaning or disinfecting.	Clean the outer surface of the pump unit using a softcloth, moistened with soapy water or 70% isopropylalcohol. Air dry only. Clean the exterior of the cuffsusing a soft cloth, moistened with soapy water or70% isopropyl alcohol.Unit must be completely dry prior to use. To ensurethat, leave the device in the OFF position anddisconnected from the wall outlet for at least 30minutes (and if necessary, for the unit to drycompletely) after cleaning or disinfecting. Do notremove the pump unit from the cuff. Do not place	Similar; both devices haveappropriate cleaning anddisinfection according todevice design.
Characteristics /Features	CIRCUL8 LuxeSubject Device	PlasmaFlowPredicate Device (K160318)	Comments
	Do not remove the pump unit from the cuff. Do notplace cuffs in dryer or microwave. Do not use a hairdryer to accelerate drying. Do not place the deviceon top or in front of portable stationary radiators toaccelerate drying. Do not use water, abrasivecleaners, oil, benzene gasoline and chemical agentsto wash the pump unit or the cuffs. Otherwise, thelife of the pump unit and cuffs will be shortened.Do not wash the cuffs, rub with cloth gently. Do notput the pump unit and cuffs near sharp things, suchas stoves, needles, scissors and so on.	cuffs in dryer or microwave. Do not use a hair dryerto accelerate drying. Do not place the device on topor in front of portable stationary radiators toaccelerate drying. Do not use abrasive cleaners.
DISPOSAL
Disposal	This unit is an electromechanical device thatincludes printed circuit boards and rechargeablebatteries. Do not discard in landfill. Consult localcounty requirements for proper disposalinstructions.Pump control units contain rechargeable batteries.Do not discard the pump unit in regular waste.Bring the unit to your local recycling center orcontact Ortho8 Inc.	This unit is an electromechanical device that includesprinted circuit boards and rechargeable batteries. Donot discard in landfill. Consult local countyrequirements for proper disposal instructions. Pumpcontrol units contain rechargeable batteries. Do notdiscard the pump unit in regular waste.Bring the unit to your local recycle center or contactManaMed.	Similar; both devices haveproper disposal instructionsin the IFU.

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Ortho8, Inc.

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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.
ElectromagneticCompatibility andElectrical 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).

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).