Consolidated SSR and SR MC-Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

Device Description

The Consolidated SR and SSR Series Sterilizers are for general purpose gravity or vacuum steam sterilization of heat and moisture-stabile goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 16 cycles can be easily accessed and are password protected. All cycle phases are sequenced and monitored by the Mark V control system, providing both audible and visual notification of deviation from certain operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of pressure or come equipped with an integral, electrically heated steam generator.

AI/ML Overview

The provided text describes a 510(k) summary for the Consolidated SSR and SR MC-Series Steam Sterilizers, Models: SSR-2A, SSR-3A, and SR-24E.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics like sterilization rates or specific temperature/pressure ranges that must be met. Instead, it asserts that the device's functionality and conformance were determined through testing. The "reported device performance" is implicitly that it did meet these unstated requirements.

Acceptance Criteria (Inferred from "Performance Testing")	Reported Device Performance
Device functionality as a steam sterilizer	Functionality determined to be acceptable through biological and physical testing.
Conformance to design input requirements	Conformance determined to be acceptable through biological and physical testing.
Substantial equivalence to predicate device (Getinge/Castle "Castle Series 100HC", K994314) in design, materials, construction, and intended use.	The Consolidated SR and SSR Series Steam Sterilizers are stated to be substantially equivalent to the predicate in design, materials, construction, and intended use, raising no new safety and efficacy concerns.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Biological and physical testing was conducted to determine device functionality and conformance to design input requirements."

Sample Size for the Test Set: Not specified. The document does not provide details on the number of sterilization cycles, biological indicators, or physical measurements performed.
Data Provenance: Not explicitly stated, but given that Consolidated Machine Corp. is a Boston, MA-based company and the FDA review process is for marketing in the US, the testing would presumably be conducted in the US. The document does not indicate if the data was retrospective or prospective, but performance testing for a new device would typically be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is an autoclave (steam sterilizer) and its performance is evaluated against physical and biological indicators, not expert interpretations of images or clinical data. "Ground truth" in this context would be the successful sterilization of materials as indicated by validated biological and physical methods.

4. Adjudication Method for the Test Set

Not applicable. (See explanation for point 3).

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

Not applicable. This is a medical device (steam sterilizer), not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device, not an algorithm. The device's performance is inherently "standalone" in its sterilization function, without human-in-the-loop performance beyond operation and loading.

7. The Type of Ground Truth Used

The ground truth used for evaluating the performance of a steam sterilizer would typically be established through:

Biological Indicators (BIs): Spore strips or vials containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that, when cultured after a sterilization cycle, show no growth if sterilization was successful.
Physical Indicators: Measurement of temperature, pressure, and time during the sterilization cycle using calibrated sensors to ensure parameters meet specified sterilization conditions.
Chemical Indicators: Color-changing strips or tags that indicate exposure to steam and/or specific sterilization conditions, though these do not prove sterility alone.
Load Specifications and Cycle Parameters: The "ground truth" and benchmark for performance are adhering to validated cycles and ensuring the device can consistently achieve these predefined, effective sterilization parameters for various loads (wrapped/unwrapped instruments, linens, liquids).

The document states, "Biological and physical testing was conducted," which aligns with the typical ground truth methods for these types of devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set" in the AI sense. The design and validation of the sterilizer are based on engineering principles and regulatory standards, not iterative training on a data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See explanation for point 8).

Summary

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K041833

10/25/04

Consolidated Machine Corporation FDA Abbreviated 510(k) - Consolidated SR and SSR MC-Series Steam Sterilizers

APPENDIX 7 510(k) Summary

DEC 1 0 2004

Consolidated Machine Corp. 76 Ashford St. Boston, Ma. 02134 Tel: 617-782-6072 Fax: 617-787-5865

510K Summary of Safety and Effectiveness June 4, 2004 Consolidated SSR and SR Series Steam Sterilizers

1. Sponsor Name

Consolidated Machine Corp. 76 Ashford St. Boston, Ma. 02134

Device Name 2.

Proprietary Name: Consolidated SSR Series and SR Series Sterilizers Models: SSR-2A, SSR-3A, and SR-24E Common Name: Steam Sterilizer or Autoclave Classification Name: Steam Sterilizer

Identification of Legally Marketed Device 3.

Getinge/Castle , "Castle Series 100HC", K994314

র্ব-Device Description

ડ. Intended Use

Consolidated SSR/SR Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

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Consolidated Machine Corporation

Comparison of Technological Characteristics 6.

The Consolidated SR and SSR Series Steam Sterilizers are substantially equivalent in design, materials, construction and intended use as those of the predicates identified above. Since the Consolidated SR and SSR Series Steam Sterilizers are the same in intended use and technological characteristics as the predicate devices, they do not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.

7. Performance Testing

Biological and physical testing was conducted to determine device functionality and conformance to design input requirements.

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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 features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines representing the branches of government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Arthur Trapotsis Director, R & D Consolidated Machine Corporation P.O. Box 297 76 Ashford Street Boston, Massachusetts 02134

DEC | 0 2004

Re: K041833

Trade/Device Name: Consolidated SSR and SR MC-Series Steam Sterilizer, Models: SSR-2A, SSR-3A, SR-24E Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: October 26, 2004 Received: October 27, 2004

Dear Mr. Trapotsis:

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. Trapotsis

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 (QS) 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 (240) 276-0115. 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 yours.

Susan Runner
Chiu-Lin, Ph.D.

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

Enclosure

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INDIICATION FOR USE STATEMENT

12041833 510(k) Number (if known): This submission

Consolidated SSR and SR MC-Series Steam Sterilizer Device Name:

Models: SSR-2A, SSR-3A, SR-24E

Indications For Use:

See attached for Load Specifications and Cycle Parameters.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Smphain Oms 12-10-04

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

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510(k) Number

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).