(77 days)
Not Found
No
The document describes a pneumatic compression device with basic electronic controls and indicators. There is no mention of AI, ML, or any complex data processing or learning capabilities. The modifications are related to physical design, display, and battery life.
Yes
The device is intended to prevent DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of various ulcers and chronic venous insufficiency, which are all therapeutic functions.
No
Explanation: The device is intended for therapeutic purposes such as preventing DVT, enhancing circulation, and reducing pain and swelling, rather than for diagnosing any conditions.
No
The device description explicitly states it is a "lightweight, portable, rechargeable battery powered prescription device" that utilizes "pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid value". This indicates the device includes significant hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for stimulating blood flow in the extremities to prevent DVT, enhance circulation, reduce pain and swelling, aid wound healing, and treat various vascular conditions. These are all therapeutic or preventative actions performed on the patient's body.
- Device Description: The description details a pneumatic system with cuffs that inflate to apply pressure to the limbs. This is a physical intervention.
- Lack of Diagnostic Activity: There is no mention of the device analyzing samples (like blood, urine, or tissue) or providing diagnostic information about a patient's condition. IVD devices are used to diagnose diseases or other conditions, including a state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Performance Studies: The performance studies focus on physical, performance, and electrical requirements of the device's operation, not on the accuracy of a diagnostic test.
Therefore, the Circul8 Pro Vascular Therapy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
JOW
Device Description
The Circul8 Pro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescription device. The device is intended to be used in the home or clinical setting by or under the direction of a medical professional by any patient needing venous return due to an increased risk from blood clots.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, lower limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescribed by a physician, for use in the home or clinical setting by or under the direction of a medical professional
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 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)
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.
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/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized human figure, while the FDA acronym and full name are written in blue. The full name of the agency is "U.S. Food & Drug Administration".
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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3
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 | taylor@pmpmed.com | |
| 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 | john@medtechreview.com | |
| 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 | ||
| intended to be used in the home or clinical setting by or under the direction of a medical professional by any patient needing venous | ||
| 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
4
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)
5
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.