(69 days)
These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.
The Jackson-Pratt® Hemaduct and the Jackson-Pratt Gold™ Hemaduct™ Wound Drains are made of silicone in a variety of sizes and are offered sterile in both flat and round configurations.
This document is a 510(k) summary for the Jackson-Pratt® Hemaduct™ and Jackson-Pratt Gold™ Hemaduct™ Wound Drains. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, much of the requested information regarding AI studies, expert consensus, and detailed ground truth establishment is not applicable to this 1997 medical device submission.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds typically associated with performance metrics for an AI device. Instead, it lists biological compatibility tests common for medical devices. The "Result" column serves as the reported performance, indicating successful compliance with these tests.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity Test | Not elicit any toxic reactions | Drain does not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity | No reactivity was observed. |
| Hemocompatibility | Hemocompatible; no lysis | Drains are hemocompatible exhibiting no lysis. |
| Systemic Toxicity | No potential for irritation | Drain does not display potential for irritation. |
| Sensitization | No potential for irritation | Drain does not display any potential for irritation. |
| Pyrogen | No pyrogenic response | Drain does not illicit a pyrogenic response. |
The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to predicate devices in terms of intended use, size, configuration, packaging, and material (silicone). The biological tests listed above support the safety aspect of this equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for each of the biological compatibility tests. It generally refers to these as "testing" rather than a clinical study with a specific patient or sample count.
- Data Provenance: Not explicitly stated. These are laboratory-based biocompatibility tests, not clinical data from specific countries or retrospective/prospective studies.
3. Number of Experts and Qualifications for Ground Truth Establishment
This information is not applicable to this type of medical device submission. The ground truth for biocompatibility tests is established by standardized laboratory protocols and scientific evaluation, not by expert consensus in the way it would be for an AI diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, primarily in AI or clinical trials. Biocompatibility tests have objective endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This submission is for a physical medical device (wound drain), not an AI-assisted diagnostic tool. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
This is not applicable. There is no algorithm or software component for this physical wound drain device.
7. Type of Ground Truth Used
The ground truth used for the reported biological tests is based on standardized laboratory test methodologies and established biological safety parameters. For example, the cytotoxicity test follows a specific protocol to assess cellular toxicity, and the pyrogen test uses a method to detect fever-inducing substances. The results are objective measurements against defined biological endpoints, not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a physical medical device, not an AI model requiring machine learning.
9. How Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set, there is no ground truth to establish for it.
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k 973703
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
DEC - 4 1997
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Jackson-Pratt® Hemaduct™ Jackson-Pratt Gold™ Hemaduct™ Wound Drains
| Manufacturer: | Allegiance Healthcare CorporationMediVac1500 Waukegan RoadMcGaw Park, Illinois 60085 |
|---|---|
| Regulatory Affairs Contact: | Joseph A. MertisAllegiance Healthcare Corporation1500 Waukegan RoadMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3310 |
| Date Summary Prepared: | September 11. 1997 |
| Product Trade Name: | Jackson-Pratt® Hemaduct™ Wound DrainJackson-Pratt Gold™ Hemaduct™ Wound Drains |
| Common Name: | Surgical Wound Drain |
| Classification: | Catheter, Irrigation (79GBX) |
| Predicate Devices: | Jackson-Pratt® Wound DrainsJohnson & Johnson Blake™ DrainZimmer Quad-Lumen™ Drain |
| Description: | The Jackson-Pratt® Hemaduct and the Jackson-Pratt Gold™Hemaduct™ Wound Drains are made of silicone in a variety of sizesand are offered sterile in both flat and round configurations, |
| Intended Use: | These wound drains are flexible, multilumen tubes, intended to beused to drain fluids (exudate) from body cavities. |
| CFR Citation: | 21CFR 878.4200 |
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The Jackson-Pratt® Hemaduct™ and the Jackson-Pratt Gold™ Equivalence: Hemaduct™ Wound Drains are substantially equivalent to Jackson-Pratt Wound Drains, the J&J Blake™ Drain and the Zimmer Quad-Lumen™ Drain in that they provide the following characteristics:
- intended use
- size, configuration, packaging
- made of silicone
Summary of Testing:
| Test | Result |
|---|---|
| Cytotoxicity Test | Drain does not elicit anytoxic reactions to acuteapplication. |
| Intracutaneous Reactivity | No reactivity was observed. |
| Hemocompatibility | Drains are hemocompatibleexhibiting no lysis. |
| Systemic Toxicity | Drain does not displaypotential for irritation. |
| Sensitization | Drain does not display anypotential for irritation. |
| Pyrogen | Drain does not illicit a pyrogenicresponse. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Mr. Joseph A. Mertis Director, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re: K973703
Trade Name: Jackson-Pratt® Hemaduct™ Wound Drains and Gold™ Hemaduct™ Wound Drains Regulatory Class: I Product Code: GBX Dated: September 24, 1997 Received: September 26, 1997
Dear Mr. Mertis:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Joseph A. Mertis
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Jackson-Pratt® Hemaduct™ Wound Drain Device Name: Jackson-Pratt Gold™ Hemaduct™Wound Drain
Indications For Use: These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.
CFR Citation - 21CFR 878.4200
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X | or | Over-The Counter Use | |
|---|---|---|---|---|
| --------------------------------------- | --------------------------------------------------- | ---- | ---------------------- | -------------------------------------------------- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K973703 |
|---|---|
| --------------- | --------------------------------------------------------- |
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.