The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Description

The MyoSURE™ Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm OD x 184 mm long stainless steel tube containing a series of rod lenses and a 3.0 mm working channel. At the distal end of the tube, an "objective" lens captures the image of the "object". The series of "rod" lenses relays the image along the length of the tube. The image is directed by a 45° prism to an offset eyepiece that also contains "rod" lenses which relay the image along the length of the eyepiece tube. At the proximal end of the eyepiece, an "ocular" lens forms the image for the human eye and/or camera. The hysteroscope features a 0° angle of view and an 80° field of view.

The MyoSURE™ Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 3 mm working channel and a proximal seal. The 3 mm working channel is dimensionally compatible with the Interlace Medical Hysteroscopic Morcellator (K073690).

Additionally, the MyoSURE™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD x 283 mm length outflow channel which may be inserted through the hysteroscope's working channel. The outflow channel includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.

The MyoSURE™ Rod Lens Hysteroscope is autoclavable and will be sold as a non-sterile, reusable device.

AI/ML Overview

The provided text describes a 510(k) summary for the MyoSURE™ Rod Lens Hysteroscope. This is a traditional medical device submission, primarily focused on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies like those for AI/ML-based devices.

Therefore, many of the requested categories for AI/ML device evaluations are not applicable to this submission. The "performance testing" section refers to compliance with standards and validation protocols typical for mechanical/optical devices, not statistical performance metrics derived from large datasets.

Here's the breakdown of the information available in relation to your request:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Safety and Biocompatibility: Compliance with ISO 10993-1 for Biological Evaluation of Medical Devices.	The MyoSURE™ Rod Lens Hysteroscope "meets the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices."
Sterilization Efficacy: Ability to adequately sterilize the device.	"The ability to adequately sterilize the device is confirmed by validation protocol."
Electrical Safety/Performance (if applicable): Compliance with IEC 60601-2-18 (specific to endoscopes).	The MyoSURE™ Rod Lens Hysteroscope "complies with applicable portions of IEC 60601-2-18."
Functional Equivalence: Design, principles of operation, primary functional specifications, and materials of composition are equivalent to predicate devices (Henke Sass Wolf Hysteroscopes, Smith & Nephew Hysteroscope, Stryker Urology and Gynecology Hardware System).	The device is equivalent to predicates in: stainless steel fabrication, rod lens optical system, autoclavable and non-sterile reusable nature. Additionally, the MyoSURE and Smith & Nephew devices employ working channels compatible with tissue morcellator devices.
Intended Use Equivalence: Identical intended use to predicate devices and Interlace Medical Hysteroscopy System (K081070).	The intended use "is identical to that of both the Interlace Medical Hysteroscopy System (K081070) and the predicate Smith & Nephew Hysteroscope (K013870)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as this is a traditional medical device submission for a hysteroscope, not an AI/ML device relying on a "test set" of clinical data in the conventional sense. Performance was demonstrated through engineering testing and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "test set" requiring expert-established ground truth for an AI/ML algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable in the context of AI/ML device evaluation. The "ground truth" for this device's performance relies on engineering standards, material specifications, and functional demonstrations typical for medical instruments. For example, sterilization efficacy is validated against microbiological sterility standards, and biocompatibility against ISO 10993.

8. The sample size for the training set

Not applicable. There is no AI/ML component or "training set."

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

Not applicable.

Summary

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Interlace Medical Inc.

న. 510(k) SUMMARY

AUG 21 2009

1. . Submitter:

Interlace Medical Inc. 135 Newbury St Framingham, MA 01701 Telephone: 508.875.1343, ext. 112

Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: May 8, 2009

2. Device:

Trade Name: MyoSURE™ Rod Lens Hysteroscope and Accessories Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II

3. Predicate Device:

Henke Sass Wolf Hysteroscopes, Hysteroscopic Resectoscopes and Accessories (K941541 / K952186 / K991563)

Smith & Nephew Hysteroscope and Accessories (K013870)

Stryker Urology and Gynecology Hardware System (K040390)

4. Device Description:

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The MyoSURE™ Rod Lens Hysteroscope is autoclavable and will be sold as a non-sterile, reusable device.

ડ. Intended Use:

The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

6. Comparison of Characteristics:

The design, principles of operation, primary functional specifications and materials of composition of the MyoSURE™ Rod Lens Hysteroscope are equivalent to those of the predicate Henke Sass Wolf (K941541 / K952186 / K991563), Smith & Nephew (K013870) and Stryker (K040390) hysteroscopes and hysteroscopic resectoscopes in that:

all devices are fabricated from stainless steel and incorporate a rod lens ● optical system,
. all hysteroscopes are autoclavable and are provided as non-sterile. reusable devices,
both the MyoSURE and Smith & Nephew devices employ working � channels that are dimensionally compatible with tissue morcellator devices.

The MyoSURE™ Rod Lens Hysteroscope's intended use is identical to that of both the Interlace Medical Hysteroscopy System (K081070) and the predicate Smith & Nephew Hysteroscope (K013870).

7. Performance Testing:

The MyoSURE™ Rod Lens Hysteroscope complies with applicable portions of IEC 60601-2-18 and meets the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. The ability to adequately sterilize the device is confirmed by validation protocol.

8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the MyoSURE™ Rod Lens Hysteroscope has been shown to be equivalent in technology, method of operation, functional performance and intended use to the previously referenced predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AUG 2 1 2009

Mr. John J. Vozella V.P. Clinical & Regulatory Affairs Interlace Medical, Inc. 135 Newbury Street FRAMINGHAM MA 01701

Re: K091465

Trade/Device Name: Myosure™ Rod Lens Hysteroscope Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: July 24, 2009 Received: July 28, 2009

Dear Mr. Vozella:

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 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.

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html far. the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Interlace Medical Inc.

Premarket Notification

4. INDICATIONS FOR USE STATEMENT

K091465 510(k) Number (if known):

Device Name: MyoSURE™ Rod Lens Hysteroscope

Indications For Use:

The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

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

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)

Aogn 72272

(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

CONFIDENTIAL

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Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.