(145 days)
Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle. These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 °C for a 4-minute minimum plus a minimum of 15 minutes drying time.
Sterilization cases, trays, and cassettes designed to hold various general dental, medical device instrumentation during the cleaning, use, and sterilization process. The design is a container (case) with separate lid, which has various methods of holding the instruments in place. These are trays and cassettes, which are made of metal and plastic. They are available in various sizes ranging from [width x length x height (depth)] 10.375 " x 21.75" x 21.75" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Carr Sterilization Cases, Trays, and Cassettes:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Attributes | |
| Holds instrumentation during cleaning, use, and sterilization cycle | Indicated for holding medical device instrumentation in place throughout entire instrument use, cleaning, and sterilization cycle. (Stated in "Indications for use" and "General Technical Characteristics") |
| Compatibility with Pulsing High Vacuum (pre-vac) steam sterilization at 132°C for 4-minute minimum with 15-minute drying time | Suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132°C for a 4-minute minimum with a 15-minute drying time. (Stated in "Indications for use" and "General Technical Characteristics") |
| Reusability | Intended to be reused: Yes. |
| Design Attributes | |
| Various sizes available | 10.375" x 21.75" x 2.5" to 10.375" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case. |
| Methods for holding instruments in place | Utilizes various methods of holding instruments in place: Yes. |
| May incorporate latch system | May incorporate latch system to hold lid in place: Yes. |
| Material Attributes | |
| Made of Aluminum, stainless steel, plastic | Yes. |
| Performance Standard Compliance | |
| Tested in accordance with AAMI TIR No. 12-1994 | Tested in accordance to AAMI TIR No. 12-1994: Yes. |
| Validation study performed with half cycles to challenge sterilization method | Validation study performed with half cycles to challenge sterilization method used: Yes. |
Note: The document does not explicitly present a "table of acceptance criteria." The criteria are inferred from the "Indications for Use" and the "General Technical Characteristics" section which outlines the device's design, materials, and performance expectations. The reported device performance is essentially a restatement or confirmation that the device meets these inferred criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The Carr Metal Products Sterilization Cases, Trays, and Cassettes were independently tested according to AAMI TIR No. 12-1994 for their performance with the Pulsing High Vacuum (prevacuum) Steam sterilization method."
- Sample Size: The document does not specify the sample size (e.g., number of cases, trays, cassettes or sterilization cycles) used for the performance testing.
- Data Provenance: The testing was conducted "independently." The country of origin of the data is not explicitly stated, but given the FDA submission, it's highly likely to be U.S.-based or conducted according to U.S. standards. The study appears to be prospective in nature, as it describes performance testing conducted specifically for the device's clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing was described as "independently tested," implying a qualified testing facility, but details on expert involvement or their qualifications are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (sterilization cases), adjudication in the context of expert review for image interpretation or diagnosis is not applicable. The testing would likely involve objective measurements (e.g., sterility indicators, temperature/pressure monitoring) rather than subjective human assessment 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening tools where reader performance is a key metric. This device is a medical device accessory (sterilization case) and does not involve AI or human "readers" in that context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a passive physical product, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on objective measurements and adherence to recognized performance standards for sterilization efficacy. Specifically:
- AAMI TIR No. 12-1994: This technical information report provides guidelines for designing and testing reusable medical device sterilization processing. Compliance with this standard implies that the device successfully maintained sterility, allowed steam penetration, and protected instruments during sterilization.
- Validation Study with Half Cycles: This indicates a robust sterilization validation process designed to confirm the effectiveness of the sterilization method even under stressed conditions. The "ground truth" would be the biological and physical indicators confirming sterility after these half-cycle challenges.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device, a method for establishing its ground truth is irrelevant.
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510(k) Summary of Safety and Effectiveness
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 January 10, 2003
| Carr Medical Products, Inc.3735 N. Arlington Ave.Indianapolis, IN 46218 | Tel - (317) 542-0691Fax - (317) 542-0694 |
|---|---|
| Official Contact: | Alan L. Booker - Operations Manager |
| Proprietary or Trade Name: | Sterilization Cases, Trays, and Cassettes |
| Common/Usual Name: | Sterilization cases, trays, and cassettes |
| Classification Name: | Sterilization Wrapper Pack, Bag, and Accessories |
| Predicate Devices: | C/T Med-Systems Cassette system (Carr MedicalProducts) - K980065Symmetry - PolyVac surgical instrument deliverysystem - K012105 |
Device Description:
Sterilization cases, trays, and cassettes designed to hold various general dental, medical device instrumentation during the cleaning, use, and sterilization process. The design is a container (case) with separate lid, which has various methods of holding the instruments in place. These are trays and cassettes, which are made of metal and plastic. They are available in various sizes ranging from [width x length x height (depth)] 10.375 " x 21.75" x 21.75" x 21.75" x 5" with trays and cassettes of similar size, which are stacked inside the case.
Indicated Use:
Medical device instrumentation cases, trays, and cassettes intended to hold instruments and accessories in place throughout the entire instrument use, cleaning, and sterilization cycle.
These cases, trays, and cassettes are suitable for Pulsing High Vacuum (pre-vac) steam sterilization at 132 ℃ for a 4-minute minimum with a 15-minute drying time.
Environment of Use:
Hospital, Operating Room (OR), physician and dental office or places where instruments are sterilized.
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 January 10, 2003
Summary of Performance testing:
The Carr Metal Products Sterilization Cases, Trays, and Cassettes were independently tested according to AAMI TIR No. 12-1994 for their performance with the Pulsing High Vacuum (prevacuum) Steam sterilization method.
General Technical Characteristics
| Attribute | Proposed devices |
|---|---|
| Indications for use | Indicated for holding medical device instrumentation inplace throughout entire instrument use, cleaning, andsterilization cycle |
| Sterilization Method | Pulsing High Vacuum (pre-vacuum) steam sterilizationat 132°C 4 minute minimum cycle with a 15-minuteminimum drying time. |
| Intended to be reused | Yes |
| Intended Environment of Use | Hospital, Operating Room (OR), physician and dentaloffice or places where instruments are sterilized |
| Design | |
| Various sizes of cases and lids and associated traysand cassettes offered | 10.375 " x 21.75" x 2.5" to 10.375" x 21.75" x 5" withtrays and cassettes of similar size, which are stackedinside the case |
| Utilizes various methods of holding instruments inplace | Yes |
| May incorporate latch system to hold lid in place | Yes |
| Materials | |
| Aluminum, stainless steel, plastic | Yes |
| Performance Standards | |
| None under Section 514 | Yes |
| Tested in accordance to AAMI TIR No. 12-1994 | Yes |
| Validation study performed with half cycles tochallenge sterilization method used | Yes |
Differences between Other Legally Marketed Predicate Devices
There are no significant differences between the intended device and the predicates, C/T Med-Systems – K980065 other than larger sizes and Symmetry – PolyVac surgical instrument delivery system - K012105.
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MAR 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carr Metal Products, Incorporated C/O Mr. Paul Dryden ProMedic, Incorporated 6329 West Waterview Court McCordsville, Indiana 46055-9501
Re: K023658
Trade/Device Name: Carr Sterilization Cases, Trays and Cassettes Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 10, 2003 Received: January 13, 2003
Dear Mr. Dryden:
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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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.
Susan Kuono
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
| 510(k) Number: | K023658 (To be assigned) |
|---|---|
| Device Name: | Carr sterilization cases, trays, and cassettes |
| Intended Use: | Medical device instrumentation cases, trays, and cassettesintended to hold instruments and accessories in placethroughout the entire instrument use, cleaning, andsterilization cycle. |
| These cases, trays, and cassettes are suitable for PulsingHigh Vacuum (pre-vac) steam sterilization at 132 °C for a4-minute minimum plus a minimum of 15 minutes dryingtime. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801.109)
or
Over-the-counter use _________________________________________________________________________________________________________________________________________________________
Clim S. Lim
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Der e 40/6) Niimb
Page 6
§ 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).