(89 days)
Not Found
Not Found
No
The summary describes a physical test pack for steam sterilizers and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a test pack for steam sterilizers, used to verify the effectiveness of sterilization processes, not to treat or diagnose a medical condition in a patient.
No
This device is used for testing steam sterilizers, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a physical integrator placed inside a test pack, indicating it is a hardware device, not software-only.
Based on the provided information, the Propper PASS/FAIL Challenge Pack is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to test the performance of steam sterilizers, which are devices used to sterilize medical instruments and materials. This is a quality control or process monitoring function, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device consists of a steam sterilization integrator within a test pack. This is designed to react to the sterilization process itself, not to detect or measure substances in a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays to detect specific analytes.
In summary, the Propper PASS/FAIL Challenge Pack is a sterilization process indicator, not a device used for diagnosing conditions in patients.
N/A
Intended Use / Indications for Use
The Propper PASS/FAIL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
Product codes
JOJ
Device Description
The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BT- O.K. M steam sterilization test pack.
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
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
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Summary of Performance Studies
Composite results from comparative testing of these products are given in the two figures which accompany this summary.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
JUL 12 1939
SUMMARY OF SAFETY AND EFFECTIVENESS
510 (k) Submission K99 [2]
Propper PASS/FAIL Challenge Pack
General Information:
Submitter's Name/Address:
Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City, NY 11101 Attn: John D. Dyckman, Ph.D.
Common Name of the Device:
Biological/Chemical Indicator
Trade Name of the Device:
PASS/FAIL Challenge Pack
Classification Information:
Class II, Sterilization Process Indicator
Indications for Use:
The Propper PASS/FATL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
Device Description:
The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BT- O.K. M steam sterilization test pack.
Substantial Equivalence:
1
The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BI- O.K.™ steam sterilization test pack.
Substantial Equivalence:
The Propper PASS/FAIL Challenge Pack is substantially equivalent to several biological test packs marketed for testing steam sterilization at 121° C in gravity displacement sterilizers or at 132-134°C in prevacuum sterilizers. Composite results from comparative testing of these products are given in the two figures which accompany this summary.
Conclusion:
Based upon the indications for use and documented performance, the Propper PASS/F AIL Challenge Pack has been shown to be both safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1.2 1999
John D. Dyckman, Ph.D. Vice President Product Research Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101 USA
Re : K991276 PASS/FAIL™ Challenge Pack Trade Name: II Requlatory Class: Product Code: JOJ Dated: May 20, 1999 Received: May 21, 1999
Dear Dr. Dyckman:
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, good 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Dr. Dyckman
this response to your premarket notification Please note: submission does not affect any 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 finding 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 diaqnostic 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 requlation entitled, "Misbranding by reference to ene regaration chercloud "hisbranding by 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,
Simon Kummer
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
510(k) Number (if known):
. Device Name:________________________________________________________________________________________________________________________________________________________________ PASS/FAIL Challenge Pack
Indications For Usc:
The Propper PASS/FAIL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | X |
|---|---|---|---|
| ------------------------------------------ | ---- | ---------------------- | --- |
| (Optional Format 1-2-96) | ||
|---|---|---|
| -- | -- | -------------------------- |
| | Qum S. Lin (Division Sign-Off) Division of Dental, Infection Control,
and General Hospital Devices 510(k) Number K991276 |
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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