(40 days)
The Wright 51 and 52 Sequential Compression System is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
The Wright 51 and 52 Sequential Compression System consists of a sequential, segmental, intermittent, pneumatic compression pump and appropriate limb appliances. It is typically used to compress an upper or lower body extremity.
The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential opening and closing of the solenoid valves, which are connected to five (5) external pressure ports. The pressure ports are connected to the limb appliance through a hose assembly.
The inflatable limb appliance is made of fabric and may comprise from one to five cells, with the length of the appliance dependent upon the physician's order or patients limb length. In operation, the pump fills the inflatable limb appliance with air, to prescribed, preset pressures -- each cell in sequence. This simple repetition of the sequence of compression and exhaust improves return blood circulation for the patient.
The Wright 51 and 52 Sequential Compression System is a medical device intended for the treatment of lymphedema, venous insufficiencies, and other edematous conditions. The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as predicate devices. | Risk Analysis: Conducted to confirm the device's safety is comparable to predicate devices. |
| Performance Specifications: Conformity to specified operational parameters for therapy delivery. | Bench Performance Testing: Measurements verified the sequence, timing, and pressure of therapy delivery. The functionality of the operator interface was also verified. |
| Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with relevant consensus standards. | Electrical Safety and EMC Testing: Conducted in accordance with consensus standards. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated. The document indicates "bench tests" were performed, implying a test set of the device itself (likely one or more units) rather than a human subject sample.
- Data Provenance: The testing was conducted by or on behalf of the manufacturer, Wright Therapy Products, located in Oakdale, PA, USA. This suggests the data is prospective, generated specifically for this 510(k) submission.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Experts: Not applicable for this type of submission. The evaluation was based on non-clinical testing (risk analysis and bench tests) against engineering specifications and consensus standards, not on expert interpretations of clinical data.
4. Adjudication Method (Test Set)
- Adjudication Method: Not applicable. The evaluation involved objective measurements and comparisons against predetermined performance specifications and safety criteria in a non-clinical setting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document explicitly states "Clinical Testing: None." The submission relies on substantial equivalence to legally marketed predicate devices through comparison of technical characteristics and non-clinical testing.
6. Standalone Performance Study
- Standalone Performance Study: Yes, in a non-clinical context. The "Nonclinical Testing" section describes a standalone evaluation of the device's performance through risk analysis, bench tests (sequence, timing, pressure, operator interface functionality), and electrical safety/EMC testing. This represents the algorithm/device-only performance in a simulated or controlled environment.
7. Type of Ground Truth Used
- Ground Truth: The ground truth for the non-clinical testing was based on:
- Engineering Specifications: Predetermined parameters for sequence, timing, and pressure of therapy delivery, as well as operator interface functionality.
- Consensus Standards: Standards for electrical safety and electromagnetic compatibility.
- Predicate Device Characteristics: The safety profile of the legally marketed predicate devices served as a benchmark for the risk analysis.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The document describes a medical device, not an AI/ML algorithm that employs a training set in the conventional sense. The device's control system uses a programmable microprocessor with software, which would have been developed and verified through standard software engineering practices, not through a 'training set' of data.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable for this device. The software controlling the pump would have been developed and verified against functional requirements and design specifications, which serve as the "ground truth" for its operation, established through engineering design processes rather than data labeling.
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Image /page/0/Picture/0 description: The image shows the logo for Wright Therapy Products. The word "Wright" is written in a bold, sans-serif font and is surrounded by two curved arrows, one above and one below. To the right of "Wright" are the words "THERAPY PRODUCTS" in a smaller, sans-serif font. The logo is black and white.
K071040
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| §807.92 (a)(1) | MAY 22 2007 |
|---|---|
| Submitter's Name:Address: | Wright Therapy Products103-B International DriveOakdale, PA 15071-3907 |
| Telephone Number: | 800-631-9535 |
| Contact Person: | Carol Wright, President and CEO |
| Date of Summary Preparation: | February 28, 2007 |
| §807.92 (a)(2)Trade Name: | Wright 51 and 52 Sequential Compression System |
| Common Names: | Lymphedema pumpPneumatic compression pump or deviceCompression pump |
| Classification Name: | Sleeve, Limb, Compressible |
| Product Code: | JOW, 21 CFR 870.5800 |
| §807.92 (a)(3) |
| Legally Marketed Substantially Equivalent Devices: | K961797 Wright Pro-Lite |
|---|---|
| K961292 Wright Solo |
$807.92 (a)(4)
Description of Device:
The Wright 51 and 52 Sequential Compression System consists of a sequential, segmental, intermittent, pneumatic compression pump and appropriate limb appliances. It is typically used to compress an upper or lower body extremity.
The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential opening and closing of the solenoid valves, which are connected to five (5) external pressure ports. The pressure ports are connected to the limb appliance through a hose assembly.
The inflatable limb appliance is made of fabric and may comprise from one to five cells, with the length of the appliance dependent upon the physician's order
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KC71040
Page 2 of 2
or patients limb length. In operation, the pump fills the inflatable limb appliance with air, to prescribed, preset pressures -- each cell in sequence. This simple repetition of the sequence of compression and exhaust improves return blood circulation for the patient.
$807.92 (a)(5)
Intended Use:
The Wright 51 and 52 Sequential Compression System is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
$807.92 (a)(6)
Comparison of Technical Characteristics
The Wright 51 and 52 Sequential Compression System is comparable to the previously cleared predicate devices:
- Same intended use
- . Same operating principle
- Similar technology .
- . Same manufacturing process
In the new therapy device the pump is controlled by software in a microprocessor along with associated electronic circuits, while the predicate devices uses relay controls. The user interface of the new device is based on a touch screen and digital display, compared to analog knobs and meters in the predicate device. The new and the predicate devices use limb appliances of the same material, with the maximum number of cells increased from three to five in the new device.
§807.92 (b)(1)
Nonclinical Testing:
The evaluation of the device consisted of risk analysis to confirm that the device is as safe as the predicate devices and bench tests to verify conformity to performance specifications. Bench performance testing consisted of measurements of the sequence, timing, and pressure of therapy delivery along with verification of the functionality of the operator interface. In addition, electrical safety and electromagnetic compatibility testing to consensus standards was conducted.
8807.92 (b)(2)
Clinical Testing: None
$807.92 (b)(3)
Conclusion
Based on the above, we conclude that the Wright 51 and 52 Sequential Compression System is substantially equivalent to the legally marketed predicate device, and does not raise any new issues of safety or effectiveness.
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2007
Wright Therapy Products c/o Barbara Majchrowski Senior Project Engineer 5200 Butler Pike Plymouth Meeting, PA 19426-1298
Re: K071040
Trade/Device Name: Wright 51 and 52 Sequential Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: April 11, 2007 Received: April 12, 2007
Dear Ms. Majchrowski:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 – Ms. Majchrowski
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duma R. Vunes
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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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
KO71040
Device Name: __ Wright 51 and 52 Sequential Compression System
Indications For Use:
The Wright 51 and 52 Sequential Compression System is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Ladner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Kozlo40
§ 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).