(69 days)
The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema -
- Venous stasis ulcers -
- Venous insufficiency -
- Peripheral edema -
The device is intended for both home and hospital use.
The CircuFlow™ 5150 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow™ 5150 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within in the first chamber can be programmed, with each successive chamber having its pressure be 7% less than the previous chamber.
This document describes the acceptance criteria and the study conducted for the Devon Medical Products, Inc. CircuFlow™ 5150 Sequential Compression Device.
1. Acceptance Criteria and Reported Device Performance:
The provided document lists several performance tests that were conducted. While the acceptance criteria (i.e., the specific thresholds the device needed to meet) are not explicitly stated in numerical terms within the document, the "Reported Device Performance" is implied by the statement "Bench and laboratory testing was performed and assures that the product meets its specifications." This suggests that all tests were passed successfully according to internal specifications.
| List of Performance Tests | Implied Reported Device Performance |
|---|---|
| Pressure Accuracy Test | Met specifications |
| Cycle Time Test | Met specifications |
| Reverse Pressure Test | Met specifications |
| Treat Time Performance | Met specifications |
| Pressure Sensor Calibration Test | Met specifications |
| Sleeve Integrity Test | Met specifications |
| Treat Time Test | Met specifications |
2. Sample Size and Data Provenance for the Test Set:
The document does not explicitly state the sample size used for each performance test. It mentions "Bench and laboratory testing," which typically refers to controlled testing environments rather than clinical trials with human subjects. The data provenance is laboratory-based testing. There is no indication of country of origin of data or whether it was retrospective or prospective in the sense of patient data.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
Not applicable. This device is a medical instrument (sequential compression device), and its performance testing as described focuses on engineering specifications rather than diagnostic interpretation requiring expert human ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As the testing focuses on engineering performance rather than human interpretation, an adjudication method for a test set is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (sequential compression device), not an AI algorithm for diagnostic interpretation. Therefore, assessing how human readers improve with or without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was effectively done. The performance tests described (e.g., Pressure Accuracy Test, Cycle Time Test) assess the device's intrinsic mechanical and electronic performance without human intervention in its operational function beyond initiation and setting parameters (which are part of its intended use). The device is designed to operate independently based on its programming and mechanics to deliver compression therapy.
7. Type of Ground Truth Used:
The ground truth for the performance tests was based on engineering specifications and established measurement standards. For example, the "Pressure Accuracy Test" would likely compare the device's output pressure to a high-precision reference pressure gauge, and "Cycle Time Test" would measure the actual cycle duration against programmed or target times.
8. Sample Size for the Training Set:
Not applicable. This device is a mechanical/electronic medical device, not an AI or machine learning model that requires a training set in the conventional sense. Its "training" is in its design, engineering, and manufacturing processes, rather than data-driven learning.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of an AI/ML model for this device. The device's operational parameters and performance targets are established through engineering design, clinical requirements for such devices, and regulatory standards.
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FEB 2 8 2013
510(K) SUMMARY
Submitter:
Devon Medical Products, Inc.
Contact Person:
Ruth Wu, COO 1100 First Avenue, Suite 202 King of Prussia, PA 19406 Phone: 610.757.4103 Fax: 610.930.4035
Common Classification & Proprietary Names:
Sequential Compression Device Common Names: CircuFlow™ 5150 Proprietary Name:
Date Prepared:
October 31rd, 2012
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the CircuFlow 10 5150.
| Classification Name | 21 CFRSection | ProductCode | Class |
|---|---|---|---|
| Compressible LimbSleeve | 870.5800 | JOW | II |
Predicate Devices:
The CircuFlow™ 5150 Sequential Compression Device is substantially equivalent to the following.
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| CircuFlow™ 5200 | Devon Medical, Inc. | K101523 |
| CircuFlow™ 5100 | Devon Medical, Inc. | K100446 |
Device Description
The CircuFlow™ 5150 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow™ 5150 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to
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prevent reverse gradient flow. Once all chambers are inflated, they are then all released
simultaneously, and the cycle repeats. Pressure within in the first chamber can be programmed, with each successive chamber having its pressure be 7% less than the previous chamber.
Intended Use:
The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema -
- Venous stasis ulcers -
- Venous insufficiency -
- Peripheral edema -
The device is intended for both home and hospital use.
Technological Characteristics:
The manufacturer believes that the technological characteristics of the CircuFlow™ 5150 are substantially equivalent to those of the predicate devices.
The CircuFlow™ 5150 has very similar components to its predicate devices and has very similar principles of operation. The device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, like the predicates, pressure is applied cyclically for a specified period of time, according to the physician's prescription.
Performance Testing
Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the CircuFlow™ 5150 are substantially similar to those of the predicate devices. The performance testing includes the following tests:
| List of Performance Tests | |
|---|---|
| Test 1 | Pressure Accuracy Test |
| Test 2 | Cycle Time Test |
| Test 3 | Reverse Pressure Test |
| Test 4 | Treat Time Performance |
| Test 5 | Pressure Sensor Calibration Test |
| Test 6 | Sleeve Integrity Test |
| Test 7 | Treat Time Test |
Standards
The CircuFlow™ 5150 conforms to the following standards:
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IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard:
AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14971 Medical devices - Application of risk management to medical devices
Statement of Substantial Equivalence
The CircuFlow™ 5150 is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Products believes that the CircuFlow™ 5150 is substantially equivalent to the predicate devices as described herein.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
Devon Medical Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street. NW Buffalo, MN 55313
Re: K123959
Trade/Device Name: CircuFlow 5150 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 15, 2013 Received: February 19, 2013
Dear Mr. Job:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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
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Page 2 - Mr. Mark Job
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Matthew Gillillebrenner
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K123959 510(k) Number (if known):
Device Name: CircuFlow™ 5150 Sequential Compression Device
Indications for Use:
The CircuFlow™ 5150 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema -
- Venous stasis ulcers -
- -Venous insufficiency
- -Peripheral edema
The device is intended for both home and hospital use.
Prescription Use ____________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G. Hillebrenner
§ 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).