K Number
K973703
Device Name
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
Date Cleared
1997-12-04

(69 days)

Product Code
Regulation Number
878.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.
Device Description
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.
More Information

Jackson-Pratt® Wound Drains, Johnson & Johnson Blake™ Drain, Zimmer Quad-Lumen™ Drain

Not Found

No
The summary describes a simple, passive wound drain made of silicone with no mention of any computational or analytical capabilities.

No
The device is a wound drain used to remove fluid (exudate) from body cavities, which is a supportive function rather than direct therapeutic intervention.

No

The device is described as a wound drain intended to remove fluids from body cavities, which is a therapeutic function rather than a diagnostic one. The performance studies also focus on biocompatibility and safety, not on detecting or identifying medical conditions.

No

The device description explicitly states the wound drains are made of silicone and are flexible, multilumen tubes, indicating a physical hardware component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "drain fluids (exudate) from body cavities." This is a therapeutic or surgical function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
  • Device Description: The description details a physical device (flexible, multilumen tubes) used for drainage, not for analyzing biological samples.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information.
  • Performance Studies: The performance studies focus on the biocompatibility and safety of the device for use within the body (cytotoxicity, hemocompatibility, etc.), not on its ability to accurately diagnose or measure something in a sample.

Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.

Product codes (comma separated list FDA assigned to the subject device)

GBX

Device Description

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,

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

body cavities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

TestResult
Cytotoxicity TestDrain does not elicit any toxic reactions to acute application.
Intracutaneous ReactivityNo reactivity was observed.
HemocompatibilityDrains are hemocompatible exhibiting no lysis.
Systemic ToxicityDrain does not display potential for irritation.
SensitizationDrain does not display any potential for irritation.
PyrogenDrain does not illicit a pyrogenic response.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Jackson-Pratt® Wound Drains, Johnson & Johnson Blake™ Drain, Zimmer Quad-Lumen™ Drain

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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 Corporation
MediVac
1500 Waukegan Road
McGaw Park, Illinois 60085 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Joseph A. Mertis
Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3310 |
| Date Summary Prepared: | September 11. 1997 |
| Product Trade Name: | Jackson-Pratt® Hemaduct™ Wound Drain
Jackson-Pratt Gold™ Hemaduct™ Wound Drains |
| Common Name: | Surgical Wound Drain |
| Classification: | Catheter, Irrigation (79GBX) |
| Predicate Devices: | Jackson-Pratt® Wound Drains
Johnson & Johnson Blake™ Drain
Zimmer Quad-Lumen™ Drain |
| Description: | 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, |
| Intended Use: | These wound drains are flexible, multilumen tubes, intended to be
used to drain fluids (exudate) from body cavities. |
| CFR Citation: | 21CFR 878.4200 |

1

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:

TestResult
Cytotoxicity TestDrain does not elicit any
toxic reactions to acute
application.
Intracutaneous ReactivityNo reactivity was observed.
HemocompatibilityDrains are hemocompatible
exhibiting no lysis.
Systemic ToxicityDrain does not display
potential for irritation.
SensitizationDrain does not display any
potential for irritation.
PyrogenDrain does not illicit a pyrogenic
response.

2

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

3

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)XorOver-The Counter Use
----------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Division Sign-Off)

Division of General Restorative Devices

510(k) NumberK973703
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