(28 days)
The Myosure XL 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.
The Myosure XL 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 4.0 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 evepiece 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 XL Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 4 mm working channel and a proximal seal.
Additionally, the Myosure XL Rod Lens Hysteroscope utilizes a removable 4.0 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 XL Rod Lens Hysteroscope is intended to be sterilized prior to use.
The provided text describes a 510(k) premarket notification for a medical device, the Myosure XL Rod Lens Hysteroscope. It focuses on demonstrating equivalence to an existing predicate device rather than presenting a study with acceptance criteria and device performance results in the way a clinical trial or AI algorithm validation would.
Therefore, many of the requested sections about study design, sample sizes, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of regulatory submission. The submission's goal is to show that the new device is substantially equivalent to a previously cleared device.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific device performance metrics in a tabular format. The submission focuses on demonstrating equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated as quantitative thresholds) | The Myosure XL Rod Lens Hysteroscope complies with the functional and performance characteristics of the predicate device including flow rate testing, and seal effectiveness associated with the use of the device. (Implies performance meets the predicate's) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document refers to "Performance Testing" but does not detail the nature of these tests, sample sizes, or data provenance. It's likely these were bench tests or engineering validations, not clinical studies in the typical sense.
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)
This information is not applicable/not provided. The document describes a physical medical device (hysteroscope), not an AI algorithm requiring expert-established ground truth for image interpretation or diagnostic performance. Performance testing likely involved engineering measurements and functional checks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically associated with expert review of diagnostic cases, which is not described here.
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
This information is not applicable. This is a physical medical device, not an AI algorithm. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of diagnostic ground truth. For a physical device, "ground truth" would refer to established engineering specifications or functional standards against which the device's physical performance (e.g., flow rate, seal effectiveness) is measured. The document states the device "complies with the functional and performance characteristics of the predicate device."
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
{0}------------------------------------------------
HOLOGIC, Inc.
Premarket Notification
DATE: September 13, 2012
ડી 510(k) SUMMARY
l. Submitter:
Hologic, Inc. 250 Campus Dr. Marlborough, MA 01752 Telephone: 508.263.8857
Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist
-
- Device:
Trade Name: MyoSure XL Rod Lens Hysteroscope Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II Regulation number: 884.1690 Product code: HIH
- Device:
Predicate Device: 3.
MyoSure Rod Lens Hysteroscope (K091465)
4. Device Description:
The Myosure XL 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 4.0 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 evepiece 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 XL Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 4 mm working channel and a proximal seal.
Additionally, the Myosure XL Rod Lens Hysteroscope utilizes a removable 4.0 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 XL Rod Lens Hysteroscope is intended to be sterilized prior to use.
SEP 19 2012
{1}------------------------------------------------
Intended Use: 5.
The Myosure XL 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 Technological Characteristics:
The design, principles of operation, primary functional specifications and materials of composition of the Myosure XL Rod Lens Hysteroscope are equivalent to those of the predicate Myosure Rod Lens Hysteroscope with the exception:
- the outer diameter of the working channel has been increased to ● 4.0mm
- the outer diameter of the hysteroscope has been increased to 6.49 x 7.64 mm (oval).
The Myosure XL Rod Lens Hysteroscope's intended use is identical to that of the predicate Myosure Rod Lens Hysteroscope (K091465).
7. Performance Testing:
The Myosure XL Rod Lens Hysteroscope complies with the functional and performance characteristics of the predicate device including flow rate testing, and seal effectiveness associated with the use of the device.
8. Conclusion:
Based on the intended use, descriptive information and performance evaluation provided in this submission, the Myosure XL 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.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Sarah Fairfield Senior Regulatory Affairs Specialist. Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752
SEP 1 9 2012
Re: K122563
Trade/Device Name: Myosure XL Rod Lens Hysteroscope Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: August 22, 2012 Received: August 22, 2012
Dear Ms. Fairfield:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your occuon >10(x) premaired is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure for segary manated provide Medical Device Ameralments, or to commerce prior to May 20, 1970, the chaoinent and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. and Cosment Act (Act) that do not require apple for the general controls provisions of the Act. The Y ou may, therefore, market the device, bactor is annual registration, listing of
general controls provisions of the Act include requirements for annual registration, listing general controls provisions of the fiel her her her hibitions against miss and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDAT does not of article labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into cation major regulations affecting your device can be
it may be subject to additional controls. Existing major regulation affic if may be subject to additional controls. DATS in and 100 to 808. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to Sederal Register found in the Code of I edelui Rogatations, concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a varies with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA nas made a decemmanon and 70 an every by other Federal agencies. You must in or any Federal statutes and regulations administed to: registration and listing and listing of media comply with all the Act STEquilients, metading, occirculars and one of the ording of medical
{3}------------------------------------------------
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related daverse overse (2) CFR Part 820); and if applicable, the electronic form in the quant) Byteriors (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 II you desire specific advice for your do receive offices/CDRHOffices/ucm115809.html for go to mus.na.gov/rtbout Britised Brill St (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance (21 GEFF the Concertification entitled, "Misbranding by reference to premarket notification" (21CFR Parti 100€ the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 I ou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
HOLOGIC, Inc.
Premarket Notification
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Myosure XL Rod Lens Hysteroscope
Indications For Use:
The Myosure XL Rod Lens Hysteroscope is used to provide viewing of the cervical canal and The Myosure XL Rod Lens Trysteroseope is assure provins and surgical procedures.
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)
Hulut Leun
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122563
§ 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.