CIRCUL8 Luxe DVT Prevention Device

K211235 · Ortho8, Inc. · JOW · Sep 8, 2021 · Cardiovascular

Device Facts

• Record ID: K211235
• Device Name: CIRCUL8 Luxe DVT Prevention Device
• Applicant: Ortho8, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Ambulatory, portable, intermittent pneumatic compression system; provides sequential compression to lower limbs. Microprocessor-controlled pump delivers air to single-bladder PVC cuffs; inflates to 60mmHg (±5mmHg) then deflates; cycle repeats until powered off. Used in home, hospital, or surgery center; prescribed by physician; operated by patient or clinician. Powered by internal 3.7V Li-ion batteries per cuff. Provides visual/audible alarms for low battery, pressure errors, or adapter faults; auto-shutdown after 30 seconds of unaddressed alarm. Benefits patient by stimulating blood flow, preventing DVT, and aiding wound healing/edema reduction.

Clinical Evidence

Bench testing only. Performance verified via pressure delivery (avg 62.03mmHg), cycle time (avg 74.8s), leakage testing, and burst pressure testing. Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10. Electrical safety and EMC verified per IEC 60601-1 and IEC 60601-1-2. Battery safety verified per IEC 62133-2.

Technological Characteristics

Microprocessor-controlled pneumatic pump; 3.7V Li-ion battery per cuff; PVC single-bladder cuffs with non-latex, non-woven polyester blend fabric. Operates at 60mmHg (±5mmHg) with 60-second cycle. Connectivity: standalone. Sterilization: clean/non-sterile. Software: moderate level of concern.

Indications for Use

Indicated for patients requiring venous return to prevent DVT, enhance circulation, reduce post-op pain/swelling, reduce wound healing time, and treat stasis dermatitis, venous stasis ulcers, arterial/diabetic leg ulcers, chronic venous insufficiency, and lower limb edema. Contraindicated for patients with severe arteriosclerosis, ischemic vascular diseases, acute/active DVT, pulmonary edema, congestive heart failure, thrombophlebitis, neuropathy, active infections, or conditions where increased venous/lymphatic return is undesirable (e.g., vein ligation, gangrene, dermatitis, open wounds, recent skin grafts, massive edema, or extreme deformity).

Regulatory Classification

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.

Predicate Devices

• PlasmaFlow Vascular Therapy System (K160318)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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# 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 | | [e-mail] | | |
| 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 | | [e-mail] | | |
| 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 /<br>Features | CIRCUL8 Luxe<br>Subject Device | PlasmaFlow<br>Predicate Device (K160318) | Comments |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | COMPARISON OF GENERAL INFORMATION / USES AND INDICATIONS | | |
| FDA Device<br>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,<br>pneumatic pressure application (inflation followed<br>by deflation) to compress the lower limb(s). | Aids venous return by using cyclic, intermittent,<br>pneumatic pressure application (inflation followed by<br>deflation) to compress the lower limb(s). | Same. |
| Intended Use | CIRCUL8 Luxe, is intended to be an easy-to-use<br>portable system, prescribed by a physician, for use<br>in the home or clinical setting to help prevent the<br>onset of DVT in patients by stimulating blood flow<br>in the extremities (simulating muscle contractions).<br>This device can be used to:<br>• Aid in the prevention of DVT;<br>• Enhance blood circulation;<br>• Diminish post-operative pain and swelling;<br>• Reduce wound healing time;<br>• Aid in the treatment and healing of: stasis<br>dermatitis, venous stasis ulcers, arterial and diabetic<br>leg ulcers, chronic venous insufficiency and<br>reduction of edema in the lower limbs.<br>The unit can also be used as an aid in the<br>prophylaxis for DVT by persons expecting to be<br>stationary for long periods of time. | The PlasmaFlow, model PF0001, is intended to be an<br>easy-to-use portable system, prescribed by a<br>physician, for use in the home or clinical setting to<br>help prevent the onset of DVT in patients by<br>stimulating blood flow in the extremities (simulating<br>muscle contractions). This device can be used to:<br>• Aid in the prevention of DVT;<br>• Enhance blood circulation;<br>• Diminish post-operative pain and swelling;<br>• Reduce wound healing time;<br>• Aid in the treatment and healing of: stasis<br>dermatitis, venous stasis ulcers, arterial and diabetic<br>leg ulcers, chronic venous insufficiency and reduction<br>of edema in the lower limbs.<br>The unit can also be used as an aid in the prophylaxis<br>for DVT by persons expecting to be stationary for<br>long periods of time. | Same. |
| Contraindication(s) | The Circul8 Luxe DVT Prevention Device must not<br>be used to treat the following conditions:<br>• Severe arteriosclerosis or other ischemic<br>vascular diseases | The PlasmaFlow must not be used to treat the<br>following conditions: Persons with suspected, active<br>or untreated: deep vein thrombosis, ischemic vascular<br>disease, severe arteriosclerosis, pulmonary edema,<br>severe congestive heart failure, thrombophlebitis or | Same. |
| Characteristics /<br>Features | CIRCUL8 Luxe<br>Subject Device | PlasmaFlow<br>Predicate Device (K160318) | Comments |
| | Acute or active deep vein thrombosis Existing pulmonary edema, pulmonary<br>embolisms, and/or congestive cardiac failure On patients with neuropathy, active<br>infections, and/or thrombophlebitis On extremities that are extremely<br>deformed, insensitive to pain, or where increased<br>venous or lymphatic return is undesirable Any local skin or tissue condition in which<br>the garments would interfere including but not<br>limited to: Vein ligation Recent skin graft Gangrene Dermatitis Open wounds Massive edema | an active infection;<br>On a leg where cuffs would interfere with the<br>following conditions: vein ligation, gangrene,<br>dermatitis, open wounds, a recent skin graft, massive<br>edema or extreme deformity of the leg; On patients<br>with neuropathy; On extremities that are insensitive<br>to pain; Where increased venous or lymphatic return<br>is undesirable | |
| Target Population /<br>Intended Users | Patients who need venous return. | Patients who need venous return. | Same. |
| Where Used | Home, Hospital, Surgery Center, Altitude travel,<br>areas of limited mobility. | Home, Hospital, Surgery Center, Altitude travel,<br>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,<br>pneumatic pressure application (inflation followed<br>by deflation) to compress the lower limb(s). | Aids venous return by using cyclic, intermittent,<br>pneumatic pressure application (inflation followed by<br>deflation) to compress the lower limb(s). | Same. |
| Characteristics /<br>Features | CIRCUL8 Luxe<br>Subject Device | PlasmaFlow<br>Predicate Device (K160318) | Comments |
| Anatomical Site /<br>Location of<br>treatment<br>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<br>has a Mode 2. Mode 1 of<br>both devices have the same<br>functionalities. |
| Working Pressure | Mode one (default) is preset at 60 mmHg<br>Pressure tolerance ±5mmHG or ~8% | Mode one and Mode two are preset at 55 mmHg | Similar; Circul8 Luxe has a<br>tolerance of ±5mmHG<br>from 60mmHG which<br>equals 55mmHG to<br>65mmHG. The predicate's<br>working pressure falls<br>within the same range. |
| Cycle Time | 60 seconds | 60 seconds | Same. |
| System indicators | Battery: BLUE=On and fully<br>operational/RED=low voltage; connect charger<br>required.<br>Pressure: numerical pressure display mmHg. | Battery: BLUE=On and fully operational /<br>RED=low voltage; connect charger required.<br>Pressure: numerical pressure display mmHg. | Same. |
| System alarms | Low Battery Error: flashing red light + alarm<br>-<br>for 30 sec .; unit turns off.<br>Pressure Error: flashing red light + alarm for 30<br>sec .; unit turns off. | Battery Critical: RED=battery charge below<br>critical level; cycling stops; alarm sounds for 10<br>sec .; unit turns off.<br>Low Pressure or Leak: Flashing red/blue and<br>error code E1 displayed if pressure limit is not | Similar; appropriate alarms<br>to mitigate risks are<br>provided in both devices,<br>however different<br>terminology is used |
| Characteristics /<br>Features | CIRCUL8 Luxe<br>Subject Device | PlasmaFlow<br>Predicate Device (K160318) | Comments |
| - | Adapter Error: intermittent flashing red/blue<br>light +alarm for 5 sec; unit turns off. | reached within 30 sec. Cycling stops; alarm<br>sounds for 10 sec .; unit turns off. | (battery critical vs low<br>battery error). |
| System diagnostics | Visual indicators prompt recognitions of systems<br>faults | Audible and visual alarms prompt recognition of<br>system faults | Similar; both devices have<br>alarms. The execution<br>differs from audible and<br>visual by the predicate and<br>only visual for Circul8<br>Luxe. Patients are properly<br>warned with a visual<br>indicator that satisfies risk<br>mitigation. |
| Battery<br>Specifications | Rating Voltage: 7.4V Li-ion battery pack<br>rechargeable (one 3.7V Li-ion in each cuff) | Rating Voltage: 7.4V Li-ion battery pack<br>rechargeable (one 3.7V Li-ion in each cuff) | Same. |
| Internal<br>rechargeable<br>batteries | Yes | Yes | Same. |
| Air delivery from<br>pump to cuff<br>bladder | Via flexible plastic (PVC) tube(s) connected<br>directly to the air bladder. | Via flexible plastic (PVC) tube(s) connected directly<br>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<br>of soft, non- latex, non-woven medical fabric (a<br>Polyester blend) or equivalent medical material for<br>increased patient comfort and biocompatibility<br>compliance. Grey colored, stitched, and thick. | Single bladder PVC chambers encased in a covering<br>of soft, non- latex, non-woven medical fabric (a<br>Polyester blend) or equivalent medical material for<br>increased patient comfort and biocompatibility<br>compliance. Grey colored, stitched, and thick. | Same. |
| Characteristics /<br>Features | CIRCUL8 Luxe<br>Subject Device | PlasmaFlow<br>Predicate Device (K16031…