(145 days)
Not Found
No
The device description and intended use are for physical containers used for sterilization, with no mention of software, data processing, or AI/ML capabilities.
No.
This device is designed to hold instruments during cleaning, use, and sterilization; it does not directly treat or diagnose a medical condition.
No
Explanation: The device is described as sterilization cases, trays, and cassettes intended to hold instruments for cleaning, use, and sterilization. It does not perform any medical diagnosis or provide diagnostic information about a patient's health.
No
The device description clearly states it is a container (case) with separate lid, trays, and cassettes made of metal and plastic, designed to hold instruments. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for holding instruments and accessories during cleaning, use, and sterilization. This is a function related to the processing and handling of medical instruments, not for performing diagnostic tests on biological samples.
- Device Description: The description details a container system for instruments, made of metal and plastic. This aligns with the intended use and does not suggest any components or functions related to in vitro diagnostics.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents
- Assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic measurements or results
- Intended User/Care Setting: While used in healthcare settings, the focus is on instrument sterilization, not diagnostic testing.
- Performance Studies: The performance studies focus on sterilization efficacy, which is relevant to instrument processing, not diagnostic performance.
In summary, the device's purpose is to facilitate the sterilization and organization of medical instruments, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
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.
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
Hospital, Operating Room (OR), physician and dental office or places where instruments are sterilized.
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)
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.
Validation study performed with half cycles to challenge sterilization method used.
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
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) 542-0691
Fax - (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 Medical
Products) - K980065
Symmetry - PolyVac surgical instrument delivery
system - 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.
1
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 in |
| place throughout entire instrument use, cleaning, and | |
| sterilization cycle | |
| Sterilization Method | Pulsing High Vacuum (pre-vacuum) steam sterilization |
| at 132°C 4 minute minimum cycle with a 15-minute | |
| minimum drying time. | |
| Intended to be reused | Yes |
| Intended Environment of Use | Hospital, Operating Room (OR), physician and dental |
| office or places where instruments are sterilized | |
| Design | |
| Various sizes of cases and lids and associated trays | |
| and cassettes offered | 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 | |
| Utilizes various methods of holding instruments in | |
| place | 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 to | |
| challenge 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.
2
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.
3
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
4
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 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. |
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
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