The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field. These covers are not intended to be used as patient drapes and have no patient contact.

Device Description

Sterile Equipment Covers

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for Sterile Equipment Covers by Volcano Corp. This device is a Class II surgical drape accessory intended to cover medical equipment to maintain a sterile field, not for patient contact.

The submission focuses on establishing substantial equivalence to predicate devices rather than proving specific performance characteristics through a detailed efficacy study with acceptance criteria and ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Expected)	Reported Device Performance (as per submission)
Sterilization Validation	All requirements for ethylene oxide (EO) sterilization (as per ANSI/AAMI/ISO 11135:1994), including sterility assurance level (SAL), residual limits, and packaging integrity after sterilization. This would typically involve demonstrating no microbial growth after sterilization, and acceptable levels of EO residuals.	"Sterilization validation testing was performed according to ANSI/AAMI/ISO 11135:1994. All requirements were met." (This is a summary statement, the detailed results are not provided in this extract).
Intended Use	The device effectively covers medical equipment to maintain a sterile field, preventing contamination from non-sterile surfaces or personnel to the equipment. This would imply physical properties sufficient for draping and barrier function.	"The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field." The performance data section does not explicitly detail testing for this, instead relying on substantial equivalence to predicates for this aspect.
Technological Characteristics	Similar design, materials, and manufacturing processes to predicate devices that achieve the intended sterile barrier function.	"The Sterile Equipment Covers uses the same fundamental scientific technology and has the same intended use and clinical applications as that of the predicate device." No specific performance metrics or comparisons are provided in this extract.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a sterilization validation study conducted according to ANSI/AAMI/ISO 11135:1994.

2. Sample size used for the test set and the data provenance:

Sterilization Validation Study: The text does not specify the sample size used for the sterilization validation testing. Typical sterilization validation studies involve multiple units per sterilization lot and multiple lots to demonstrate consistency and achieve the required Sterility Assurance Level (SAL).
Data Provenance: The text does not explicitly state the country of origin for the sterilization validation data, but it is implied to be part of the manufacturer's (Volcano Corp., located in Rancho Cordova, CA, USA) internal testing or a contracted lab. The study is prospective in nature, as it's a validation test performed as part of device development and regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the sterilization validation study, "ground truth" is established by the accepted standards and protocols defined in ANSI/AAMI/ISO 11135:1994. The "experts" would be the microbiologists and sterilization specialists involved in designing, executing, and interpreting the validation tests. Their qualifications would typically involve degrees in microbiology, biology, or related fields, with experience in medical device sterilization. The specific number or qualifications are not detailed in the provided text.

4. Adjudication method for the test set:

For sterilization validation, there is no "adjudication method" in the human consensus sense. The results are objectively determined (e.g., presence/absence of microbial growth, chemical analysis for residuals) and compared against the pre-defined criteria of the standard. Deviations or failures would lead to re-testing or process modification.

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 conducted. This type of study is relevant for diagnostic imaging devices involving human interpretation, often assisted by AI. The Sterile Equipment Covers are a physical barrier device, not an AI-powered diagnostic tool.

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 does not involve an algorithm or AI.

7. The type of ground truth used:

For the sterilization validation study, the ground truth is based on microbiological assay results (e.g., sterility testing, bioburden determination), chemical analysis (e.g., ethylene oxide residual testing), and physical property testing (e.g., package integrity) as defined and accepted by the ANSI/AAMI/ISO 11135:1994 standard.

8. The sample size for the training set:

There is no training set in the context of AI or machine learning for this device. The product is a physical medical device.

9. How the ground truth for the training set was established:

Not applicable as there is no training set for this type of device.

In summary:

The provided information focuses on a 510(k) submission for a physical medical device, not an AI/software-as-a-medical-device. The primary performance evidence presented is a statement of compliance with a recognized sterilization standard (ANSI/AAMI/ISO 11135:1994), which effectively serves as the "study" proving the device meets its key safety and performance acceptance criteria for sterility. The concept of "ground truth," "experts," "AI assistance," and "training/test sets" as applied to AI/ML algorithms is not relevant to this submission.

Summary

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Submitter: Volcano Corp.

2005 DEC 1

Sterile Equipment Covers 510(k) Premarket Notification

510 (k) Summary Sterile Equipment Covers

Date Prepared:	August 30, 2005
Submitted by:	Volcano Corp.2870 Kilgore Rd.Rancho Cordova, CA 95670
Contact person:	Michelle J. Badal, RACRegulatory Affairs Manager
Phone number:Facsimile number:	(916) 861-0287 or (800) 228-4728 ext. 287(916) 638-8112
Device Name:	Sterile Equipment Covers

Classification name:

878.4370 Surgical drape and drape accessories

Class II

Predicate Device:

The Sterile Equipment Covers are substantially equivalent to the MicroTek Equipment Drapes cleared under K050322 on May 17, 2005, Medline Band Bags and Equipment Covers cleared under K032065 on September 22, 2003, and United States Surgical Corporation cleared under K961699 on August 23, 1996. The Volcano Sterife Equipment Covers have the same Intended Use and utilizes the same fundamental scientific technology as that of the predicate devices.

Device Description:

Sterile Equipment Covers

Intended Use:

Device Technological Characteristics and Comparison to Predicate Device:

The Sterile Equipment Covers uses the same fundamental scientific technology and has the same intended use and clinical applications as that of the predicate device.

Performance Data:

Sterilization validation testing was performed according to ANSI/AAMI/ISO 11135:1994. All requirements were met.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 2005

Ms. Michelle J. Badal, RAC Manager, Regulatory Volcano Corporation 2870 Kilgore Road Rancho Cordova, California 95670

Re: K052395

Trade/Device Name: Sterile Equipment Covers Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 23, 2005 Received: November 28, 2005

Dear Ms. Badal:

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 rortions 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 appear and 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 - Ms. Badal

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 Incall that I DA mas made a assossions administered by other Federal agencies. of the Act of ally I ouchar backs requirements, including, but not limited to: registration 1 od interest comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 er reverts 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) This letter will anon you to began finding of substantial equivalence of your device to a premarket notified bevice 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), If you desire specific at 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 may obtain 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/industry/support/index.html.

Sincerely vours,

Sarette Y. Michael Oms

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

510(k) Number (if known): K052395

Sterile Equipment Covers Device Name:

Indications For Use:

The Sterile Equipment Covers are intended to be used to cover medical

equipment in order to maintain the sterile field. These covers are not

intended to be used as patient drapes and have no patient contact.

Prescription Use x AND/OR CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use ________(Part 21

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hale P. Murphy, MD 11/30/05

Sign-Off)
ision of Anesthesiology, General Hospital,
ection Control, Dental Devices
Page 1 of 2

Number: K 052 593

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.