The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Device Description

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is a device composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards and can be sterilized by steam, ethylene oxide gas and irradiation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH.

Based on the provided document, the device described is a sterilization pouch, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study details associated with AI medical devices (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sizes for algorithms) are not applicable.

The "acceptance criteria" for this type of device primarily revolve around demonstrating substantial equivalence to predicate devices and meeting established material and performance standards for sterilization pouches.

Here's an interpretation of the information requested, adapted to the context of this traditional medical device:

Acceptance Criteria and Study for MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria/Performance Goal	Reported Device Performance / How Met
Intended Use	To enclose another medical device for sterilization by a health provider (steam or ethylene oxide), allow sterilization, and maintain sterility until use.	The device's stated "Indications for Use" directly match this. Substantial equivalence relies on the identical intended use compared to predicate devices.
Composition	Composed of medical paper, bleached wet strength paper, conforming to recognized material standards.	The device description explicitly states it is "composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards." This is directly compared to predicate devices which also use "identical materials."
Sterilization Compatibility	Can be sterilized by steam, ethylene oxide gas, and irradiation.	The device description states it "can be sterilized by steam, ethylene oxide gas and irradiation." This capability is inherent to the material and design, matching that of the predicate devices.
Substantial Equivalence	Demonstrated to be substantially equivalent to legally marketed predicate devices.	The submission claims the device is "substantially equivalent to the Global Healthcare Self-Sealing Sterilization Pouch (K990567) and the Defend Self-Sealing Sterilization Pouch (K932056)." The FDA's letter (K993764) confirms this determination.
Manufacturing Quality	Compliance with Good Manufacturing Practice (GMP) regulations (21 CFR Part 820).	The FDA letter explicitly states, "A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions." The manufacturer is ISO9002-EN46002 CERTIFIED FACTOR.
Material/Performance Standards	Implicitly, performance standards related to barrier properties, seal strength, and material integrity post-sterilization (though not explicitly detailed in the summary).	The summary states, "all specifications and test results are applicable to each [predicate device] as well as to the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH." This indicates that the new device meets the same performance specifications as the predicate devices, which would have undergone such testing.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a separate "test set" in the context of an algorithmic assessment. The product's acceptance is based on its identical nature to established predicate devices already on the market.
Data Provenance: The "data" (specifications and test results) are derived from the same manufacturer producing identical products (Medipack Medical Packaging Manufacturing Co.) for Global Healthcare (K990567) and Defend (K932056). This implies existing, possibly retrospective, test results for those predicate devices are being leveraged.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable for this type of device. The "ground truth" here is compliance with material specifications and functional performance (e.g., maintaining sterility), which are typically assessed through laboratory testing and engineering standards, not expert consensus on diagnostic images.

4. Adjudication method for the test set:

Not applicable. There is no expert adjudication process described, as this is not a diagnostic device requiring interpretation of data.

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 sterilization pouch, not an AI system. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's acceptance is primarily based on engineering specifications, material science standards, and performance testing data (e.g., sterility maintenance, seal strength, compatibility with sterilization methods) that were established for the predicate devices. This data demonstrates that the materials and design lead to a functional product that meets its intended purpose.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that uses training sets.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set or ground truth in the context of AI was established.

In summary, the approval of the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is based on its substantial equivalence to already approved predicate devices. This equivalence is established because the device has the same intended use, is composed of identical materials, and is produced by the same manufacturer, implying it meets the same specifications and test results as the predicate devices. The FDA affirmation means they found sufficient evidence to conclude that the new device is as safe and effective as the predicate devices already on the market.

Summary

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MEDIPACK MEDICAL PACI

Lin-Kuo 4" Industrial Guel. Shan Helang, Tac

Image /page/0/Picture/2 description: The image shows a circular seal with the text "ISO9002-EN46002 CERTIFIED FACTOR" around the perimeter. In the center of the seal are two overlapping shapes that appear to be stylized letters. Above the seal, the text "MFG. CO." is printed in a smaller font size.

K993764

DEC I 6 1999

3. SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR IDENTIFICATION: A.

Medipack Medical Packaging Manufacturing Co. Lin-Kuo 4th Industrial Park No. 13, Tin Hu Road Guei-Shan Hsiang Tao-Yuan Hsien 333 Taiwan

Tel: 886-3-327-5678 Fax: 886-3-327-5599 medipack@ms13.hinet.net

ESTABLISHMENT REGISTRATION NUMBER: B. 9880261

C. OFFICIAL CONTACT PERSON

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac . MD 20854

Tel. : (301) 519-1098 Fax : (301) 519-1389

DATE OF PREPARATION OF THIS SUMMARY: D. November 4, 1999

MEDIPACK® SEE-THROUGH PROPRIETARY (TRADE) NAME: E. SELF SEAL STERILIZATION POUCH

00001:

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F.	COMMON NAME:	Sterilization Pouch
G.	CLASSIFICATION NAME:	Pack, Sterilization Wrapper, Bagand Accessories
H.	PROPOSED REGULATORY CLASS:	Class II
I.	DEVICE PRODUCT CODE:	KCT
J.	REFERENCE:	21CFR par.880.6850
K.	PANEL:	General Hospital

DESCRIPTION: L.

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION

POUCH is a device composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards and can be sterilized by steam, ethylene oxide gas and irradiation.

M. INDICATIONS FOR USE:

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is intended to be used to enclose another medical device that is to be sterilized by a health provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

N. PREDICATE DEVICE:

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is substantially equivalent to the Global Healthcare Self-Sealing Sterilization Pouch (K990567) and the Defend Self-Sealing Sterilization Pouch (K932056).

0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH and the predicate devices have the same intended use and all are composed of the identical materials and have identical Indications for Use. All are produced by the same manufacturer!

P. SUMMARY OF STUDIES:

Since the manufacturer, Medical Corporation, produces the identical product for the Global Healthcare and Carl Parker Associates (Defend Selfsealing Pouch), all specifications and test results are applicable to each as well as
to the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH

00001

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 6 1999

Medipack - Medical Packing Manufacturing Co. c/o Mr. Norman F. Estrin Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD -20854

Re: K993764

Medipack® See-Through Self Seal Trade Name: Sterilization Pouch Requlatory Class: II Product Code: KCT November 4, 1999 Dated: Received: November 8, 1999

Dear Mr. Estrin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Estrin

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, 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,

Susan Punger

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

MEDIPACK® SEE-THROUGH Device Name: SELF SEAL STERILIZATION POUCH

Indications for Use:

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is

intended to be used to enclose another medical device that is to be sterilized by a health provider by steam or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

Olin S. Lin

Division Sign-Off) invision of Dental, Infection Co and General Hospita ി(k) Number

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).