(112 days)
Paragon Medical's Surgical Instrument Delivery Systems are containment devices for medical device sterilization, The Systems are constructed of metal and/or plastic with perforations to facilitate steam penetration. They are to be used with an approved sterilization wrap. Sterilization Cycle: Prevacuum 132°C for 4 minutes Dry Time 20-40 minutes
Paragon Medical Surgical Instrument Delivery Systems consist of various sizes of metal, plastic, and combination cases and trays with removable lids. The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation. The products are constructed of durable materials and designed with perforations or slots to allow for steam penetration. They are to be used with an appropriate sterilization wrap.
It looks like the provided text is a 510(k) summary for a medical device (Paragon Medical Surgical Instrument Delivery System), not a study report with detailed acceptance criteria and performance metrics for an AI/device algorithm.
Therefore, many of the requested items (sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of document, as it describes a physical sterilization container, not a diagnostic or AI-driven device.
However, I can extract the "performance testing" information that somewhat aligns with "acceptance criteria" for this specific type of device.
Here's an attempt to answer based on the provided text, focusing on the relevant sections:
Acceptance Criteria and Device Performance for Paragon Medical Surgical Instrument Delivery System
Given this is a 510(k) for a physical sterilization container, the "acceptance criteria" and "performance" relate to its ability to facilitate sterilization and protect instruments, rather than diagnostic accuracy.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effective sterilization during steam sterilization and drying cycles | "Various sizes of double wrapped Cases and Trays from the System, fully loaded with medical instrumentation including some with lumens(cannulae) of up to 15" in length x 0.093 dia. have been demonstrated to be effectively sterilized using bioindicators and thermocouples in a 132°C Prevacuum 4 minute cycle. Drying time is from 20-40 minutes." |
| Protection of medical instrumentation during sterilization and storage | (Implied by the device's main function and statement that "The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation." The performance testing focuses on sterilization efficacy, suggesting protection is assumed if sterilization occurs effectively within the container.) |
| Compatibility with appropriate sterilization wrap | "They are to be used with an appropriate sterilization wrap." (This is a condition of use rather than a performance metric proved by the study itself, but essential for the system's function.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "Various sizes of double wrapped Cases and Trays from the System." It does not specify an exact number of cases/trays tested for sterilization efficacy.
- Data Provenance: The study was conducted by Paragon Medical, Inc. (device manufacturer) for the purpose of a 510(k) submission to the FDA. It is a prospective validation of the device's design and function. The country of origin of the data is implicitly the USA as the company and submission are based there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device. The ground truth (effective sterilization) was established through objective measurements using bioindicators and thermocouples, not expert human interpretation.
4. Adjudication method for the test set
This is not applicable as the ground truth was established by objective measurements (bioindicators and thermocouples) rather than human interpretation requiring adjudication.
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
This is not applicable. This device is a physical sterilization container, not an AI-driven or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical sterilization container and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was objective measurement of sterilization efficacy using:
- Bioindicators: To confirm microbial kill.
- Thermocouples: To confirm temperature attainment during sterilization.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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OCT 2 9 2003
510(k) Summary Pursuant to 21 CFR 807.92
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Submitted By: Paragon Medical, Inc. 8 Matchett Industrial Park Drive Pierceton, IN 46562
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Cory D. Colman Contact: Paragon Medical, Inc. 8 Matchett Industrial Park Drive Pierceton, IN 46562 (574) 594-2140
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- Product: Paragon Medical Surgical Instrument Delivery System CFR Section 880.6850 Sterilization Wrap Class II Pack, Sterilization Wrapper, Bag and Accessories Product Code 80 KCT
Description:
Paragon Medical Surgical Instrument Delivery Systems consist of various sizes of metal, plastic, and combination cases and trays with removable lids. The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation. The products are constructed of durable materials and designed with perforations or slots to allow for steam penetration. They are to be used with an appropriate sterilization wrap.
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Intended Use:
The Paragon Medical Surgical Instrument Delivery System is intended to hold and protect medical instrumentation during sterilization processes and subsequent storage.
Technological Characteristics and Substantial Equivalence:
The Paragon Devices are primarily constructed of machined, formed, or molded plastic and metal and do not feature any new technological characteristics or materials.
The Paragon Medical. Surgical Instrument Delivery System is comparable in design to that of the PolyVac Surgical Instrument Delivery System manufactured by Symmetry Medical, Inc. (# K102105), and that of MetaPak Multi Purpose Instrument Tray, manufactured by Riley Medical, Inc. (# K993535)
Performance Testing:
The Surgical Instrument Delivery System has been validated to perform effectively during steam sterilization and drying cycles. Various sizes of double wrapped Cases and Trays from the System, fully loaded with medical instrumentation including some with lumens(cannulae) of up to 15" in length x 0.093 dia. have been demonstrated to be effectively sterilized using bioindicators and thermocouples in a 132°C Prevacuum 4 minute cycle. Drying time is from 20-40 minutes.
Conclusions:
The Paragon Medical, Surgical Instrument Delivery System is substantially equivalent to similar devices existing in the market in materials of construction, dimensions, and performance characteristics. It has been shown to be an effective design and when used according to instructions for use, is a useful and valuable device.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Mr. Cory D. Colman Executive Vice President, Business Development Paragon Medical, Incorporated 8 Matchett Industrial Park Drive Pierceton, Indiana 46562
Re: K032119
Trade/Device Name: Paragon Medical Surgical Instrument Delivery System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 12, 2003 Received: September 16, 2003
Dear Mr. Colman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Colman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Chris
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
| 510(k) Number: | K032119 |
|---|---|
| Device Name: | Paragon Medical Surgical Instrument Delivery System |
| Intended Use: | Paragon Medical's Surgical Instrument Delivery Systems are containment devices for medical device sterilization, The Systems are constructed of metal and/or plastic with perforations to facilitate steam penetration. They are to be used with an approved sterilization wrap. Sterilization Cycle: Prevacuum 132°C for 4 minutes Dry Time 20-40 minutes |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susanna F. Barru
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K032119 |
|---|---|
| ---------------- | --------- |
| Prescription Use (Per CFR 801.109) | or | Over-the-counter Use |
|---|---|---|
| ------------------------------------ | ---- | ---------------------- |
§ 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).