(38 days)
Not Found
No
The device description and intended use clearly define a physical sterilization pouch with no mention of software, data processing, or AI/ML terms.
No
This device is a sterilization pouch used to maintain the sterility of other medical devices; it does not directly treat or diagnose a patient's condition.
No
Explanation: The device is a sterilization pouch used to maintain sterility of other medical devices. It does not perform any diagnostic function.
No
The device description clearly states it is composed of medical paper, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose and sterilize other medical devices, and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the materials and sterilization compatibility of the pouch itself.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This sterilization pouch does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health provider
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)
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
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.
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
§ 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).
0
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.
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:
1
| F. | COMMON NAME: | Sterilization Pouch |
|---|---|---|
| G. | CLASSIFICATION NAME: | Pack, Sterilization Wrapper, Bag |
| and 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
2
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
3
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
4
Page 1 of 1
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