(50 days)
The Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.
The provided text describes a Special 510(k) Summary for the Genadyne A4-XLR8 Wound Vacuum System, which is a modification of a legally marketed predicate device (Genadyne A4 Wound Vacuum System, K082676).
This type of submission focuses on demonstrating substantial equivalence to an existing device rather than a comprehensive study proving a device meets specific acceptance criteria in the context of AI/machine learning. Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as it outlines a regulatory pathway for a conventional medical device modification, not an AI-powered diagnostic or predictive tool.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or reported device performance in the manner typically seen for AI/ML device evaluations (e.g., sensitivity, specificity, AUC thresholds). Instead, the "performance" is demonstrated through equivalence testing against a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Material Equivalence | Device materials are evaluated and found equivalent. |
| Technology Equivalence | Device technology is evaluated and found equivalent. |
| Product Specifications Equivalence | Device specifications are evaluated and found equivalent. |
| Energy Requirements Equivalence | Device energy requirements are evaluated and found equivalent. |
| Safe and Effective Use (Overall) | Performance testing and device comparison demonstrates the subject device is substantially equivalent, safe, and effective for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document refers to "performance testing" and "device comparison" as part of demonstrating substantial equivalence, but it does not specify a clinical "test set" in the context of an AI/ML algorithm. The evaluation would have involved engineering and functional tests rather than a patient data test set.
- Data Provenance: Not applicable. No patient data is referred to in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of expert-established ground truth for a test set, as this is not an AI/ML device requiring such evaluation.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication in the context of AI/ML evaluation is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done. If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a negative pressure wound therapy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The concept of "ground truth" in the context of clinical AI/ML validation is not applicable here. The "truth" for this device is its functional compliance with specifications and its substantial equivalence to the predicate device in terms of design, materials, and intended use as assessed through engineering and bench testing.
8. The sample size for the training set
- Not applicable. No training set for an AI/ML algorithm is mentioned or relevant to this device.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm is mentioned or relevant to this device.
Summary of the Study/Evaluation described in the document:
The provided document describes a Special 510(k) submission for a modified medical device. The "study" referenced is the performance testing and device comparison conducted to demonstrate that the new device (Genadyne A4-XLR8 Wound Vacuum System) is substantially equivalent to its predicate device (Genadyne A4 Wound Vacuum System, K082676).
The key aspects of this evaluation, as stated in the document, involved assessing:
- Indications for Use
- Material
- Technology
- Product Specifications
- Energy Requirements
The conclusion is that the new device is "substantially equivalent to the predicate device, and is safe and effective for the intended use" based on these evaluations. This is a regulatory pathway for modifications to existing devices, where the primary "proof" is the demonstration of equivalence to a device already cleared by the FDA, rather than novel clinical trials or extensive AI/ML performance validation.
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K090636 page 1/2
Special 510k Summary
General Information
-
- Applicant:
Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 (t) 516.487.8787 (f) 516.487.7878 www.genadyne.com
- Applicant:
APR 2 9 2009
-
- Contact Person: Mr. Chien-Ming GOH (Andrew) Vice President Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 Tel: 516-487-8787 Fax: 516-487-7878 Andrew@genadyne.com
3. Trade/Proprietary Name Including Model Number of Device:
Genadyne A4-XLR8 Wound Vacuum System
4. Common Name or Classification Name (21 CFR Part 807.87) of Device:
Powered Suction Pump (21 CFR 878.4780, Product Code
OMP)
5. Class in which Device has been placed:
- Class II
6. Reason for Premarket Notification:
Introduction of a new device that is a modification of a legally marketed device.
7. Identification of Legally Marketed Device Which We Claim Substantial Equivalence (Predicate Device):
Genadyne A4 Wound Vacuum System (K082676)
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K090638 page 2/2
8. Compliance with Requirements of the Federal FD&C Act:
The General and Restorative Device Panel (DGRD) has classified this device as Class II, 21 CFR 878.4780
OMP Product Code:
9. Kit Certification and Information:
This device kit is exactly the same as its predicate device (K082676)
10. Description of the Device
The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.
11. Intended use of the Device
Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
12. Substantial Equivalence
In establishing substantial equivalence to the predicate device. Genadyne Biotechnologies evaluated the indications for use, material, technology, product specifications, and energy requirements of the system. Performance testing has been completed to demonstrate the safe and effective use of the Genadyne A4-XLR8 Wound Vacuum System for the intended use.
13. Summary of Safety and Effectiveness
Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & 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
APR 9 9 2009
Genadyne Biotechnologies, Inc. % Mr. Chien-Ming Goh Vice President 65 Watermill Lane Great Neck, New York 11021
Re: K090638
Trade/Device Name: Genadyne A4-XLR8 Wound Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: April 20, 2009 Received: April 23, 2009
Dear Mr. Goh:
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.
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 (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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
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Page 2 - Mr. Chien-Ming Goh
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
For Nelo V
O.K.
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Genadyne A4-XLR8 Wound Vacuum System
Indications For Use:
The Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
Prescription Use (Per 21 CFR 801 Subpart D)
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)
Daniel Krane fee MXM
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K990638
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.