(132 days)
The Omni Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Omni Hysteroscope is a hysteroscope consisting of a (base) rigid hysteroscope with optics and lighting connections. The Omni Hysteroscope includes three compatible sheaths, one diagnostic and two operative, that attach to the base scope; Omni 3.7 mm Diagnostic Sheath, Omni 5.5 mm Operative Sheath, and Omni 6mm Operative Sheath. The Omni Hysteroscope also includes removable outflow channels for fluid drainage. The Omni Hysteroscope is supplied non-sterile and is designed for multiple use with the device being cleaned and sterilized prior to each use.
This document, K182006, describes the 510(k) premarket notification for the Omni Hysteroscope. It focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-driven system. Therefore, much of the requested information regarding AI model performance, ground truth establishment, expert adjudication, MRMC studies, and training set details for AI-based devices is not applicable.
Here's the information that can be extracted relevant to the performance testing described for the Omni Hysteroscope:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines various design verification tests conducted to ensure the device meets its specifications. It does not provide specific numerical acceptance criteria (e.g., "Field of view must be X degrees") nor does it report precise numerical performance results (e.g., "Field of view was measured at Y degrees"). Instead, it states that the devices comply with design specifications and that test results demonstrate substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance (Compliance Statement) |
|---|---|
| Dimensional Verification | Complies with design specifications |
| Objective Lens Testing (Field of view, focal length, depth of field, direction of view) | Complies with design specifications |
| Level of Illumination | Complies with design specifications |
| Luminous Energy Transmission Ratio | Complies with design specifications |
| Magnification (eyepiece) | Complies with design specifications |
| Image Quality (Resolution, Distortion) | Complies with design specifications |
| Risk Management (ISO 14971:2007) | Risks are mitigated to an acceptable level; benefits outweigh residual risks |
| Biocompatibility (ANSI AAMI ISO 10993-1:2009) | Patient contacting materials are biocompatible and comply with requirements |
| Electrical Safety (ANSI AAMI ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/R)2012 & A2:2010/(R)2012 and IEC 60601-2-18:2009) | Testing was performed and passed |
| Usability Testing (FDA Guidance, IEC 62366-1:2015) | Testing was conducted in accordance with guidance and standards |
| Cleaning Validation | Successfully performed |
| Sterilization (ISO 14937:2009/(R)2013, ANSI/AAMI/ISO 17665-1:2006/(R)2013) | Sterilizations were conducted in accordance with standards |
2. Sample Size Used for the Test Set and Data Provenance:
This document refers to "design verification testing" and "performance testing" of the physical device. It does not involve a "test set" in the context of an AI model using patient data. The provenance of the data is implicitly from Hologic, Inc.'s internal testing facilities. It is a prospective generation of test data based on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a physical medical device (hysteroscope), not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance relates to engineering specifications and physical measurements.
4. Adjudication Method for the Test Set:
Not applicable. There is no adjudication in the context of this device. Performance is measured against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI algorithms that assist human readers. The Omni Hysteroscope is a tool for viewing and performing procedures.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The Omni Hysteroscope is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on engineering specifications and established regulatory and industry standards for medical devices (e.g., ISO, ANSI AAMI for biocompatibility, electrical safety, sterilization, etc.). For example, objective lens testing would have specific optical parameters as the ground truth.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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December 6, 2018
Hologic, Inc. Rachelle Fitzgerald Senior Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752
Re: K182006
Trade/Device Name: Omni Hysteroscope - Omni Hysteroscope (60-200), Omni 3.7 mm Diagnostic Sheath (60-201), Omni 5.5 mm Operative Sheath (60-202), Omni 6 mm Operative Sheath (60-203), Operating Room set (60-205-1), Office set (60-250-2) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: November 8, 2018 Received: November 9, 2018
Dear Rachelle Fitzgerald:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for 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
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Indications for Use
510(k) Number (if known) K182006
Device Name
Omni Hysteroscope - Omni hysteroscope (60-200), Omni 3.7 mm Diagnostic Sheath (60-201), Omni 5.5mm Operative Sheath (60-202), Omni 6mm Operative Sheath (60-203), Operating Room set (60-250-1), Office set (60-250-2)
Indications for Use (Describe)
The Omni Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
Date: November 8, 2018
510(k) Submitter:
Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Rachelle D. Fitzgerald P: 508.263.8631 F: 877.793.6434
Establishment Registration Number: 1222780
Trade Name: Omni Hysteroscope - Omni hysteroscope (60-200), Omni 3.7 mm Diagnostic Sheath (60-201), Omni 5.5mm Operative Sheath (60-202), Omni 6mm Operative Sheath (60-203), Operating Room set (60-250-1), Office set (60-250-2)
Common/Usual Name: Hysteroscope
Regulation Name: Hysteroscope and Accessories
Regulation Number: 21 CFR 884.1690
Product Code: HIH, Hysteroscope and Accessories
Classification: Class II
Panel: Obstetrics/Gynecology
PREDICATE DEVICES
Tradename: MyoSure XL Rod Lens Hysteroscope Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K122563 Product Code: HIH Regulation: 21CFR 884.1690
Tradename: MyoSure Rod Lens Hysteroscope Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K091465 Product Code: HIH
Regulation: 21CFR 884.1690
The MyoSure and MyoSure XL Rod Lens Hysteroscopes have not been subject to a designrelated recall.
DEVICE DESCRIPTION
The Omni Hysteroscope is used to provide viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedure. The Omni Hysteroscope is a
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hysteroscope consisting of a (base) rigid hysteroscope with optics and lighting connections. The Omni Hysteroscope includes three compatible sheaths, one diagnostic and two operative, that attach to the base scope; Omni 3.7 mm Diagnostic Sheath, Omni 5.5 mm Operative Sheath, and Omni 6mm Operative Sheath. The Omni Hysteroscope also includes removable outflow channels for fluid drainage.
The Omni Hysteroscope is supplied non-sterile and is designed for multiple use with the device being cleaned and sterilized prior to each use.
INDICATIONS FOR USE:
The Omni Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Omni Hysteroscope intended use is identical to the predicates MyoSure XL Hysteroscopes.
TECHNOLOGICAL CHARACTERISTICS:
Primary specifications for the Omni Hysteroscope including light source, thermal and electrical safety are identical to the predicate MyoSure XL Hysteroscope. The hysteroscope dimensions and materials of construction in the Omni Hysteroscope are similar to the predicate MyoSure and MyoSure XL Rod Lens Hysteroscope.
The mode of operation including method of use and mechanism of action, are identical to the predicate MyoSure XL Rod Lens Hysteroscope and are similar to the secondary predicate MyoSure Rod Lens Hysteroscope.
The primary differences between the proposed Omni Hysteroscope and the predicate MyoSure and MyoSure XL Rod Lens Hysteroscopes are as follows:
- The Omni Hysteroscope does not have an integrated working channel as the predicates do. ● Rather the subject devices have removable sheaths for the working channels of the Omni Hysteroscope.
- The Omni Hysteroscope utilizes simlar materials of construction as the predicate hysteroscopes with the addition of polyphenylsulfone (PPSU) and black, blue, and green colorants.
- . The working length of the Omni Hysteroscope is longer than the predicates MyoSure and MyoSure XL Rod Lens Hysteroscopes.
- The outer diameters of the Omni Hysteroscope 3.7mm diagnostic sheath and 5.5mm operative sheath are smaller than the outer diameter of the predicate MyoSure Rod Lens Hysteroscope.
- The outer diameter of the Omni Hysteroscope 6 mm operative sheath is smaller than the outer diameter predicate MyoSure XL Rod Lens Hysteroscope.
The differences in technological characteristics do not raise different questions of safety and effectiveness.
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| Characteristic | Omni Hysteroscope | Primary PredicateDevice (K122563) | Secondary PredicateDevice (K091465) |
|---|---|---|---|
| Intended Use | The Omni Hysteroscope is usedto provide viewing of thecervical canal and the uterinecavity for the purpose ofperforming diagnostic andsurgical procedures. | The MyoSure Rod Lens Hysteroscope is used toprovide viewing of the cervical canal and the uterinecavity for the purpose of performing diagnostic andsurgical procedures. | The MyoSure Rod Lens Hysteroscope is used toprovide viewing of the cervical canal and the uterinecavity for the purpose of performing diagnostic andsurgical procedures. |
| Prescription Only | Yes | Same | Same |
| Design | Rigid Hysteroscope | Same | Same |
| Patient ContactingMaterials | Stainless steel, Sapphire,Optical Glass, PEEK, GlassFiber, PPSU (black, blue, andgreen colorant), Nickel Silver | Stainless steel,Sapphire, OpticalGlass, PEEK, GlassFiber, PPSU,NickelSilver | Stainless steel, Sapphire,Optical Glass, PEEK,Glass Fiber, Nickel Silver |
| Working length | 200 mm | 184 mm | 184 mm |
| Outer diameter | 3.7-4.8 mm x 3.7- 7.5 mm | 6.5 x 7.6 mm | 6.0 x 6.4 mm |
| Light Source | Metal Halide or Xenon ≤300w | Same | Same |
| Biocompatibility | According to ANSI AAMI ISO10993-1:2009 | Same | Same |
PERFORMANCE TESTING
Design verification testing demonstrates devices comply with design specifications. Design verification testing of the Omni Hysteroscope included:
- Dimensional verification
- . Objective lens testing (Field of view, focal length, depth of field, direction of view)
- o Level of Illumination
- Luminous Energy Transmission Ratio
- Magnification (eyepiece) ●
- o Image Quality (Resolution, Distortion)
Risk management activities in accordance with ISO 14971:2007 demonstrate the risks associated with the use of the Omni Hysteroscope are mitigated to an acceptable level. Analyses of these activities indicate the benefits associated with the use of the Omni Hysteroscope outweigh the residual risks. Material analysis and testing demonstrate the patient contacting materials are biocompatible and comply with the requirements of ANSI AAMI ISO 10993-1:2009. Electrical safety testing was performed and passed ANSI AAMI ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/R)2012 & A2:2010/(R)2012 and IEC 60601-2-18:2009. Usability testing was conducted in accordance with the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices, issued on February 3, 2016 and IEC 62366-1:2015 Medical Devices – Part 1: application of usability engineering to medical devices. A cleaning validation of the Omni Hysteroscope was successfully performed and sterilizations of the Omni hysteroscope were conducted in accordance with ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements
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for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 17665-1:2006/(R)2013 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Performance testing demonstrates that the performance of the Omni Hysteroscope is substantially equivalent to the predicate devices.
CONCLUSION
Based on the intended use, descriptive information and performance provided in this submission, the Omni Hysteroscope has been shown to be substantially equivalent to the predicate MyoSure and MyoSure XL Rod Lens Hysteroscopes.
§ 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.