Circul8 Pro

K212731 · Ortho8, Inc. · JOW · Nov 15, 2021 · Cardiovascular

Device Facts

• Record ID: K212731
• Device Name: Circul8 Pro
• Applicant: Ortho8, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 15, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Circul8 Pro Vascular Therapy System 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 (stimulating 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 dermatits, 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

Portable, rechargeable, battery-powered vascular therapy system; used in home or clinical settings by patients under physician direction. Device consists of electronically controlled air pump, solenoid valve, and single-chamber inflatable cuff. System delivers 55 mmHg pneumatic compression to lower limbs to stimulate blood flow and muscle contractions. Operation involves cyclic inflation and deflation; inflation phase followed by rest period. Device features LED display for status (pressure, battery, alerts) and 'Night Mode' to minimize light disturbance. Output provides mechanical compression to aid venous return and reduce edema. Healthcare providers use device to manage DVT risk and wound healing; patient benefits from portable, easy-to-use therapy for stationary periods or post-operative recovery.

Clinical Evidence

Bench testing only. No clinical data. Verification testing confirmed physical requirements (size, weight, material), performance (inflation pressure accuracy, Night Mode functionality), and electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2).

Technological Characteristics

ABS plastic housing; pneumatically controlled single-chamber cuffs; electronically controlled air pump and solenoid valve. Powered by 3.7V 1800mAh lithium battery. Dimensions: 140x70x40 mm; weight <0.5 kg. Connectivity: None (USB port removed). Software-controlled inflation to 55 mmHg ± 10%. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2.

Indications for Use

Indicated for patients requiring venous return due to increased risk of blood clots, including those needing DVT prophylaxis, circulation enhancement, post-operative pain/swelling reduction, wound healing, or treatment of stasis dermatitis, venous/arterial/diabetic ulcers, chronic venous insufficiency, and lower limb edema.

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

• Circul8 Pro Vascular Therapy System (K193020)
• VenaOne (K200285)

Submission Summary (Full Text)

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November 15, 2021

Ortho8 Inc. % John Beasley Senior Consultant MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 89015

Re: K212731

Trade/Device Name: Circul8 Pro Vascular Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 15, 2021 Received: October 18, 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 medical devices and radiation-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.

for 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

Submission Number (if known)

K212731

Device Name

Circul8 Pro Vascular Therapy System

Indications for Use (Describe)

The Circul8 Pro Vascular Therapy System 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 (stimulating 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 dermatits, 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

K212731 page 1 of 3

## Contact Details

21 CFR 807.92(a)(1)

| Applicant Name | Ortho8 Inc. | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------|
| Applicant Address | 2217 Plaza Drive Rocklin CA 95765 United States | |
| Applicant Contact Telephone | 916-289-4002 | |
| Applicant Contact | Ms. Nordeen Taylor | |
| Applicant Contact Email | [e-mail] | |
| Correspondent Name | MedTech Review, LLC | |
| Correspondent Address | 257 Garnet Garden Street Henderson NV 89015 United States | |
| Correspondent Contact Telephone | 612-889-5168 | |
| Correspondent Contact | Mr. John Beasley | |
| Correspondent Contact Email | [e-mail] | |
| Device Trade Name | Circul8 Pro Vascular Therapy System | |
| Common Name | Compressible Limb Sleeve | |
| Classification Name | Compressible Limb Sleeve | |
| Regulation Number | 21 CFR 870.5800 | |
| Product Code | JOW | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K193020 | Circul8 Pro Vascular Therapy System | JOW |
| K200285 | VenaOne | JOW |
| The Circul8 Pro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescription device. The device is<br>intended to be used in the home or clinical setting by or under the direction of a medical professional by any patient needing venous<br>return due to an increased risk from blood clots. | | |

The Circul8 Pro Vascular Therapy System is intended to be an easy to use portable 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 (stimulating muscle

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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, 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.

## Indications for Use Comparison

The indications for use of the predicate device and the subject device are the same.

## Technological Comparison

21 CFR 807.92(a)(6)

21 CFR 807 92(a)(5)

The subject device is a modification of the predicate device in K193020, which includes:

- modification of the plastic housing the electronically controlled air pump unit and solenoid valve,

- relocation of the tactile touch control switch from the front of the housing to the housing,
- introduction of LED display to replace the tricolored LED for ON, LOW BATTERY, CHARGE COMPLETED indications, and the blue LED for indicating a leak or low pressure alarm,

- removal of the micro USB port for obtaining usage (patient compliance) data,

- no longer labeling cuff as either left leg cuff or right leg cuff,

- cuffs are filled to 55 mmHg pressure

- introduces Night Mode, which minimizes light disturbances from the LEDs during patient resting times.

- increased battery life.

The subject device has the identical performance characteristics to the predicate device in K193020. The circuit board in the subject device is updated to fit within the newly designed plastic case, which does not change any product performance. Additionally, the circuit board is updated to accommodate the relocation of the removal of the micro USB connector and the connection of the power adapter. The circuit board is also updated with a new charging circuit for the battery. Software is updated to accommodate the LED screen and Night Mode. None of these updates change the device performance. The differences between the modified (subject) device and the original (predicate) device do not raise any new issues of safety or efficacy.

The subject device is substantially equivalent to the predicate and reference device in function and operating principles to achieve identical results. The predicate device utilizes a microprocessor controlled pump to deliver approximately 50 mmHg of pressurized air to bladders that are attached to the patient's lower lime of approximately 60 seconds while the subject device is designed to deliver approximately 55 mmHg (reference device: VenaOne, K200285). Each cycle consists of inflation of a bladder, followed by a rest period during which the bladder deflates and the limb relaxes without any compression.

Both the subject device and predicate device utilize pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid value of trol components are protectively housed in a plastic case that is permanently attached to the inflatable cuff. The chape of the protective plastic case do not raise any new issues of safety or effectiveness.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Ortho8 performed the following design verification testing on the modified Circul8 Pro (L10):

(a) Physical Requirements:

- Test 1. Unit size to be no smaller than 140 X 70X 40 mm
- Test 2. Unit weight to be no more than Less than 0.5 kg
- Test 3. Housing material of construction confirmed to be ABS
- Test 4. New location of On/Off is confirmed located on the top side the device
- Test 5. LED screen correctly displays "LP" for low pressure alert, "55mmHg" for operating pressure, " " during cycles, and battery status

Test 6. Device correctly displays usage hours when power on

Test 7. Leg wrap size, shape are identical (no distinctions between Left and Right cuffs)

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Design verification test results demonstrate the true mean (average) proportion, with a 5% margin of error and at the 90% confidence level, comply with Physical Requirements #1, #2, #3, #4, #5, #6, and #7.

(b) Performance Requirements:

Test 1: Inflation pressure accuracy of the pressure switch and software in the device correctly controls inflation of the wrap to 55 mmHg ± 10% (substantially the same preset pressure used by the predicate devices)

Test 2: Night mode performed as specified in the software design input

Design verification test results demonstrate the true mean (average) proportion, with a 5% margin of error and at the 90% confidence level, comply with Performance Requirements #1, and #2.

#### (c) Electrical Requirements:

Test 1: Confirm 3.7V, 1800mAh battery and 100 - 240 Vac, 50 - 60 Hz, Output: 5Vdc @2.0 Amp power supply

Design verification test results demonstrate of the true mean (average) proportion, with a 5% margin of error and at the 90% confidence level, comply with Electrical Requirement #1.

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

(e) IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equirements for basic safety and essential performance;

(f) IEC 60601-1-2:2014, Medical electrical equipments for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests

(g) IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirement for medical electrical equipment and medical electrical systems used in the home healthcare environment, and

(h) IEC 62133-2:2017+AMD1:2021, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

Design validation test results demonstrate the modified Circul8Pro (L10) device complies with general electrical safety requirements, electromagnetic compatibility requirements for use in home healthcare environment, and requirements for secondary lithium cells and batteries for use in portable applications.

The verification of software used in the modified Circul8Pro (L10) device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

These results demonstrate the modified Circul8Pro (L10) device is as safe, as effective, and performs as well as or better than the legally marketed device predicate.