(160 days)
Not Found
No
The device description and intended use are for a rigid container system for sterilization and storage of medical instruments. There is no mention of AI or ML in the provided text.
No
The device is a container system for sterilizing and storing medical instruments, not a device used for treating patients.
No
Explanation: This device is a container system designed for the sterilization and storage of medical and dental instruments. Its purpose is to maintain sterility, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines a physical container system with a base, lid, filter retainer, seal, and latching mechanism. This is a hardware device designed for sterilization and storage of medical instruments.
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 a "Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage." This describes a device used for processing and storing medical instruments, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description details a physical container with a base, lid, filter retainer, seal, and latching mechanism. This aligns with a sterilization and storage container, not an IVD device which typically involves reagents, test strips, or analytical components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The focus is entirely on maintaining the sterility of instruments.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Prevacuum steam and EO sterilization. Sterility assurance tested up to 30 days.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
A rigid container system include a base available in several depth sizes ( 2.5", 3.0", 3.5", 4.0" and 5.0") and a lid which fits any of the bases. The lid is a standard size which fits any size (depth) of base, it also incorporates a filter retainer unit which holds a disposable filter, has a seal and incorporates a latching mechanism which latches the lid and base together.
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
- Used and handled by healthcare personnel such as - central supply, operating room nurses, surgical nurses, dental assistants, or healthcare personnel who have responsibility for the cleaning, handling, sterilization and storage of medical and dental (excluding dental hand pieces) instruments.
- Used in health care facilities hospitals, nursing homes, extended care facilities, free standing surgical centers, clinics and medical and dental offices. Within these facilities the setting may be where medical and dental (excluding dental hand pieces) instruments which are required to be sterile are utilized. Examples are - operating rooms - acute, sub-acute, outpatient surgery, physician and dental offices, wards, central services of a hospital.
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 Container system was independently tested according to AAMI ST 33, ANSI / AAMI ST 41-1992 and ST 24-1192 for its performance under two(2) sterilization methods - Pre-vacuum steam (270° - 275° F) and Ethylone Oxide (EO). It passed all criteria specific to sterilization containers and maintained a shelf life sterility of at least 30 days.
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.
Aesculap - K792558, Medin - K833343, InstruMed - K844672 and Riley - K871202
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
Carr Metal Products, Inc. 3735 N. Arlington Ave.
Indianapolis, IN 46218
NOV 1 3 1997
Non-Coalidential Summary of Safety and Effectiveness
page 1 of 4 November 7, 1997
Tel - (317) 542-0691 Fax - (317) 542-0694
| Official Contact: | Alan Booker - Operations Manager |
|---|---|
| Proprietary or Trade Name: | Carr Sterilization Container System |
| Common/Usual Name: | Sterilization Container - rigid |
| Classification Name: | Sterilization wrap |
| Device: | Carr Sterilization Container system |
| Predicate Devices: | Aesculap - K792558, Medin - K833343, InstruMed - K844672 |
| and Riley - K871202 |
Device Description:
Carr Metal Products, Inc.
3735 N. Arlington Ave. Indianapolis, IN 46218
A rigid container system include a base available in several depth sizes ( 2.5", 3.0", 3.5", 4.0" and 5.0") and a lid which fits any of the bases. The lid is a standard size which fits any size (depth) of base, it also incorporates a filter retainer unit which holds a disposable filter, has a seal and incorporates a latching mechanism which latches the lid and base together.
- Container system designed to contain medical and dental (excluding dental Indicated Use -hand pieces) instruments for sterilization, storage, and transportation. Suitable for Pre-vacuum steam and EO sterilization. Used and handled by healthcare personnel such as - central supply, operating room nurses, surgical nurses, dental assistants, or healthcare personnel who have responsibility for the cleaning, handling, sterilization and storage of medical and dental (excluding dental hand pieces) instruments.
- Environment of Use -- Used in health care facilities hospitals, nursing homes, extended care facilities, free standing surgical centers, clinics and medical and dental offices. Within these facilities the setting may be where medical and dental (excluding dental hand pieces) instruments which are required to be sterile
1
Non-Confidential Summary of Safety and Effectiveness
page 2 of 4
November 7, 1997
are utilized. Examples are - operating rooms - acute, sub-acute, outpatient
are utilized. Examples are - operating rooms - acutes services of a hospital. are utilized. Examples are - operating rooms - a2009.
surgery, physician and dental offices, wards, central services of a hospital.
Summary of Performance Testing --
ce Testing -The Carr Container system was independently tested ecording to AAMI ST
The Carr Container and ST 24-1192 for its performance under The Carr Container system was independently bases
33, ANSI / AAMI ST 41-1992 and ST 24-1192 for its performance under
33, ANSI / AAMI ST 41-1992 and ST 24-1192 for its perfor 33, ANSI / AAMI ST 41-1992 and ST 24-11-2 154 -12-11-11-11
two(2) sterilization methods - Pre-vacuum steam ( (2700 - 2750 F) and two(2) sterilization methods - Pre-vacuum siealis (1275
Ethylone Oxide (EO). It passed all criteria specific to sterilization containers
Ethylone Oxide (EO). It passed all c Ethylene Oxide (EO). It passed as .
and maintained a shelf life sterility of at least 30 days.
The staintained a shelf life sterility of at least 30 days.
maintained a shell like story.
| Comparison to Predicate Devices: | ||
|---|---|---|
| Attribute | Carr Container | Aesculap |
| K792558 or other | ||
| referenced predicates | ||
| Use | ||
| Indicated for holding instruments | ||
| to be sterilized and stored | Yes | Yes |
| Intended to be reused | Yes | Yes |
| Methods of sterilization - | ||
| pre-vacuum steam (2700F - 2750F) | ||
| for a minimum of 4 minutes | ||
| ethylene oxide follow sterilizer | ||
| manufacturer's recommendations | ||
| Minimum 12 hours aeration | Yes | Yes |
| Design | ||
| Various sizes(2.5, 3.0, 3.5, 4.0, 5.0") depth | ||
| of bases offered | Yes | Yes |
| Incorporates a filter to permit entry | ||
| of steriliant agent and prevent microbial | ||
| migration during storage | Yes | Yes |
| Utilizes latch system to hold | ||
| lid in place | Yes | Yes |
| page 3 of 4 | ||
| November 7, 1997 | ||
| Carr Container | ||
| Attribute | Aesculap | |
| K792558 or other | ||
| referenced predicates | ||
| Design | ||
| Filter retainer does not have direct align- | ||
| ment holes preventing accidental puncture | Yes | No |
| media of filter | Yes | |
| Incorporates a silicone seal within lid | Yes | Yes |
| Utilizes trays to hold instruments | Yes | Yes |
| in place | Yes | Yes |
| Has a tamper evident device slot | Yes | |
| Outside labeling slot | ||
| Useful life subject to user handling | ||
| and routine inspection after each use | Yes | Yes |
| Performance Standards / Specifications | ||
| AAMI ST 33-R-11/95 Standard testing and requirements | Yes | Claimed by Aesculap |
| K792558 | ||
| 3.2 Permits transfer of contaminated materials | Yes | Claimed by |
| Aesculap K792558 | ||
| 3.3.1 Removable filter assembly disassembles | Yes | On Aesculap K792558 |
| 3.3.4 Labeling - reusable labels | Yes | Claimed by IntsruMed |
| K844672 | ||
| 3.4 - 3.5 Instructions provided for different cleaning | ||
| methods | Yes | Assumed provided |
| 3.6 - 4.2 Instructions for inspections | Yes | |
| 6.2.2 Sterilization - manufacturer documentation | ||
| available | Yes | Claimed by Medin |
| K833343, InstruMed | ||
| K844672 | ||
| 6.2.3 Drying time in labeling | Yes | Assumed |
| 6.2.4 EO residual removal - in labeling | Yes | Assumed |
| 6.2.5 Sterility maintenance - discussed in labeling, | ||
| claimed in independent testing | Yes | InstruMed K844672 |
2
Non-Confidential Summary of Safety and Effectiveness
Confidential Summary of Safety on
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3
Non-Confidential Summary of Safety and Effectiveness
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November 7, 1997
| Attribute | Carr Container | Aesculap |
|---|---|---|
| K792558 or other | ||
| referenced predicates | ||
| The first of the first of the country of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the consisted on the |
| Performance Standards / Specifications | ||
|---|---|---|
| 6.3 User (basic) responsibilities listed in labeling | Yes | Assumed |
| 7.3.1 Routine inspection in labeling | Yes | Assumed |
| Testing of container under a challenge per | ||
| ANSI / AAMI ST 41-1992 and ST24-1992 | ||
| for prevacuum steam and EO sterilization | Passed | Claimed by Medin in |
| literature - K833343 | ||
| Claim of at least 30 days sterility shelflife | ||
| supported by test data | Yes | InstruMed K844672 |
| Validation study performed to determine | ||
| that contents would be sterile utilizing pre- | ||
| vacuum steam and ethylene oxide | Yes | Claimed by Aesculap |
| K792558, Medin | ||
| K833343 | ||
| Materials | ||
| Aluminum for lid and base | Yes | Yes |
| Coating for lid and base | Yes | Yes |
| Approved filter media | Yes | Yes |
Differences Between Other Legally Marketed Predicate Devices
There are no significant differences between the intended device and the predicate - Aesculap approved under K792558, Medin - K833343, InstruMed - K844672 and Riley - K871202.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Booker Operations Manager Carr Metal Products, Incorporated 3735 N. Arlington Avenue Indianapolis, Indiana 46218
NOV 1 3 1997
K972138 Re : Carr Rigid Container System Trade Name: Regulatory Class: II Product Code: FRG Dated: September 5, 1997 Received: September 8, 1997
Dear Mr. Booker:
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 aqainst 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 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 Reqister. Please note: this response to your premarket notification 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. →
5
Page 2 - Mr. Booker
This letter will allow you to begin marketing your device as first feet wire as 0 (k) premarket notification. The FDA described in your sit (i) privalence of your device to a legally Finding or subbeancear equite in a classification for your markets produce, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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 obcathed from the Division of Smart Manufaceardin (201) 443-6597 milli its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
11/12/199/ 12:20 31.1-335-9278
INDICATIONS FOR USE
Page 1 of 1
510(k) Number: K972138
Carr Rigid Sterilization Container System Device Name:
Container system designed to contain medical and dental Intended Use : (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Prevacuum steam and EO sterilization. Sterility assurance tested up to 30 days.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reorge L. Melle for Olin S. Zin Ph D
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K977138 510(k) Number .
Prescription Use (Per CFR 801.109)
OL
Over-the-counter use