The Imalux OCT (Optical Coherence Tomography) Probe Sheath is a sterile, single-use, protective sheath that is used as an accessory with the Imalux OCT Imaging System. The Imalux OCT Probe Sheath is intended to serve as a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.

Device Description

The Imalux OCT (Optical Coherence Tomography) Probe Sheaths (Probe Sheaths) are sterile, single-use, protective sheaths for use with the Imalux OCT Imaging System. The sheaths are provided to fit the Imalux OCT Imaging System probe geometry and to help to prevent the transfer of microorganisms, body fluids, and material to the patient and healthcare worker during reuse of the Probe. The Probe Sheath does not impair the imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material. The Probe Sheath is constructed of rigid tubing with a flexible end cap membrane window at one end and with a plastic handle at the other end. The probe is inserted into the tubing at the handle and fed through the tubing until the probe's distal tip is flush with the Probe Sheath's membrane window. The handle includes a lock nut to secure the probe in place. The Probe Sheath is provided in various dimensional configurations necessary to accommodate the probe as well as to assist the user in probe positioning. Probe Sheaths are provided as sterile, single-use sheaths, individually packaged in Tyvek/Mylar pouches.

AI/ML Overview

The medical device is the Imalux OCT Probe Sheath. The information provided describes the device, its intended use, and the testing conducted to demonstrate its safety and performance for 510(k) clearance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility
- Cytotoxicity	Evaluated per AAMI/ANSI/ISO 10993: Device is non-toxic.
- Acute systemic toxicity	Evaluated per AAMI/ANSI/ISO 10993: Device is non-toxic.
- Intracutaneous reactivity	Evaluated per AAMI/ANSI/ISO 10993: Device is non-irritating.
- Sensitization	Evaluated per AAMI/ANSI/ISO 10993: Device is non-sensitizing.
- Ethylene oxide sterilization residuals	Evaluated per AAMI/ANSI/ISO 10993: Can be safely sterilized with ethylene oxide.
Imaging Performance
- Not impair optical imaging performance of OCT system	The Probe Sheath's materials and design have been shown to not impair the optical imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material.
Mechanical Performance
- Withstand normal use (e.g., tensile strength)	Mechanical verification of the Sheath, such as tensile strength, demonstrated that the Probe Sheath's distal end will withstand normal use.
Microbial Barrier Performance
- Prevent transmission of microorganisms/fluids	Microbial barrier testing demonstrated that the Probe Sheath was capable of preventing the transmission of a challenge virus with a diameter of 25-27 nanometers (nm), smaller than most clinically relevant bacteria (1 µm diameter) and viruses (0.1 µm diameter), to a detection limit of less than 5.5 x 107 milliliters (mL) of challenge virus suspension.
Sterilization & Packaging Integrity
- Successful sterilization	The Probe Sheath, individually packaged in its Tyvek/Mylar package, was successfully sterilized with 100% ethylene oxide.
- Sterility Assurance Level (SAL)	The sterilization was validated and verified to provide a sterility assurance level (SAL) of 10-6.
- Packaging strength and integrity	The Tyvek/Mylar package was verified for strength and integrity.

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

The document does not specify the exact sample sizes used for each test (biocompatibility, imaging, mechanical, microbial barrier, sterilization, packaging). It states "The Probe Sheath was verified for imaging, mechanical, and packaging performance" and "Microbial barrier testing demonstrated..." without providing specific numbers of units tested.

The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. These were laboratory and performance tests, not clinical studies involving patient data.

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

This information is not applicable to the type of testing described. The tests are laboratory-based performance and safety evaluations (e.g., sterilization validation, material strength, microbial barrier efficacy, biocompatibility). There is no "ground truth" established by human experts in the context of interpreting results, as would be the case for an AI diagnostic device.

4. Adjudication method for the test set

Not applicable. The tests are objective, laboratory-based physical, chemical, and biological evaluations, not requiring human adjudication of subjective interpretations.

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 device is a probe sheath, an accessory to an imaging system, not an AI diagnostic algorithm. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a probe sheath and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed is based on established scientific standards and methods, such as:

Biocompatibility: Standards like AAMI/ANSI/ISO 10993 and FDA Blue Book Memorandum #G95-1, with results determined through laboratory assays for cytotoxicity, toxicity, reactivity, and sensitization.
Mechanical & Imaging Performance: Engineering specifications and objective measurements (e.g., tensile strength testing, optical clarity measurements).
Microbial Barrier: Laboratory challenge tests using a known virus size and concentration and measuring transmission.
Sterilization: Validation per established sterilization standards to achieve a specific Sterility Assurance Level (SAL).

8. The sample size for the training set

Not applicable. This device is a physical accessory, not an AI model requiring a training set.

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

Not applicable. This device is a physical accessory and does not involve a training set or AI model.

Summary

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JUN 2 5 2004 510(k) SUMMARY

This summary is being submitted in accordance with 21 CFR 807.92.

Submitter's name, address, telephone number, initial importer, contact A. person

Submitter's Name:	Imalux Corporation
Address:	1771 East 30th Street
Address:	Cleveland, OH 44114
Official Contact:	Stephanie A. S. Harrington
Title:	Vice President, Regulatory & ClinicalAffairs
Telephone:	216 502-0755
Fax:	216 622-0723
E-mail:	harrington@imalux.com

Device Name, Common Name B.

Common/Usual Name 1.

Probe Sheath

Device Name 2.

Imalux OCT Probe Sheath

Classification Name 3.

Name	ClassificationRegulation	Product Code	Class
System, Imaging, OpticalCoherence Tomography(OCT)	892.1560	NQQ	II

C. Identification of the predicate or legally marketed device

Device Name	510(k) Number
CIVCO Medical Instruments Synthetic PolyisopreneUltrasound Transducer Cover	K013721
Vision-Sciences Slide-On™ EndoSheath® System foruse with Flexible ENT Scopes	K990354

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Device Description D.

Summary 1.

The Probe Sheath does not impair the imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material.

Design 2.

The Probe Sheath is constructed of rigid tubing with a flexible end cap membrane window at one end and with a plastic handle at the other end. The probe is inserted into the tubing at the handle and fed through the tubing until the probe's distal tip is flush with the Probe Sheath's membrane window. The handle includes a lock nut to secure the probe in place. The Probe Sheath is provided in various dimensional configurations necessary to accommodate the probe as well as to assist the user in probe positioning.

Probe Sheaths are provided as sterile, single-use sheaths, individually packaged in Tyvek/Mylar pouches.

Materials 3.

The Probe Sheath is constructed of commonly used medical device materials and has been evaluated for biocompatibility. This evaluation has demonstrated that the Probe Sheath is safe for its intended use.

The intended use and indications for use place the Probe Sheath in the device body contact categories as follows:

a. surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (<24 hours)
b. external communicating devices, tissue communicating, limited contact duration (<24 hours)

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Intended Üse E.

The Imalux OCT (Optical Coherence Tomography) Probe Sheath is a sterile, single-use, protective sheath for use as an accessory with the Imalux OCT Imaging System. The Probe Sheath is intended to serve as a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.

The Imalux OCT Probe Sheath is substantially equivalent in safety and performance to the CIVCO Synthetic Polyisoprene Ultrasound Transducer Cover and to the Vision-Sciences EndoSheaths (Section C).

Safety & Performance F.

To assure the safety of the device, the Probe Sheath was tested for biocompatibility per AAMI/ANSI/ISO 10993 for cytotoxicity, acute systemic toxicity, intracuteanous reactivity, sensitization, and ethylene oxide sterilization residuals. Testing was performed in accordance with ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices 21 CFR Part 58 (GLP). These tests demonstrated that the Probe Sheath device is non-toxic, non-irritating, non-sensitizing, and can be safely sterilized with ethylene oxide.

The Probe Sheath was verified for imaging, mechanical, and packaging performance. The Probe Sheath's materials and design have been shown to not impair the optical imaging performance of the Imalux OCT Imaging System. Mechanical verification of the Sheath, such as tensile strength, demonstrated that the Probe Sheath's distal end will withstand normal use.

Microbial barrier testing demonstrated that the Probe Sheath was carable of preventing the transmission of a challenge virus with a diameter of 25-27 nanometers (nm), smaller than most clinically claimeter (1 22 to a detection limit of less than 5.5 x 107 milliliters (mL) of challenge virus suspension.

The Probe Sheath, individually packaged in its Tyvek/Mylar package, was successfully sterilized with 100% ethylene oxide. The sterilization was seconding broad and verified to provide a sterility assurance level (SAL) of 10 . In addition, the Tyvek/Mylar package was verified for strength and integrity.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

JUN 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stephanie A. S. Harrington Vice President, Regulatory and Clinical Affairs Imalux Corporation 1771 East 30th Street Cleveland, Ohio 44114

Re: K041077

Trade/Device Name: Imalux OCT Probe Sheath Regulation Number: 878.4370, 892.1560 Regulation Name: Surgical Drape and Drape Accessories, Ultrasonic Pulsed Echo Imaging System Regulatory Class: II Product Code: KKX, NQQ Dated: May 28, 2004 Received: June 1, 2004

Dear Ms. Harrington:

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 -- Ms. Harrington

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 (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.

Chris Lins, 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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INDICATIONS FOR USE

K041077 510(k) Number (if known):

Device Name:

Imalux OCT Probe Sheath

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly

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

510(k) Number: K

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.