(85 days)
The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
The Schoelly Cystoscope/Hysteroscope and Accessories comprise several models of rigid endoscopes as well as rigid endoscopic sheaths, obturators, and instrument bridges; the currently marketed system also includes a flexible grasping forceps. This Premarket Notification adds two rigid cystoscope/hysteroscope accessories (optical scissors and optical grasping forceps), both of which have been designed and are intended for use with the currently marketed Schoelly 4mm rigid cystoscope/hysteroscope and 20Fr sheath cleared in K150158. There are no changes to any of the other system components or accessories, nor are there any changes to the Schoelly Cystoscope/Hysteroscope and Accessories indications for use. The optical scissors and optical grasping forceps accessories both consist of a rigid shaft with an inner lumen that accommodates the 4mm Schoelly Cystoscope/Hysteroscope. The outer diameter and the working length of both accessories are 4.6mm and 266mm, respectively. During application, the scissor or the forceps can be attached to the cystoscope via a simple mechanical locking located at the very proximal portion of the devices. The scissor or grasper is then inserted through a 20Fr Schoelly Cystoscope/Hysteroscope Sheath while being connected to the Schoelly Cystoscope/Hysteroscope. Another mechanical locking mechanism allows the user to lock all three coaxial components (scope, scissor/grasper accessory, and sheath) together. The scissor and grasper accessories incorporate a control handle. Operation of the control handle actuates the distal tip double action jaws via a pull wire mechanism. The optical scissor and grasper accessories are made entirely of stainless steel. The accessories are reusable instruments that are supplied nonsterile.
The provided text is a 510(k) premarket notification for a medical device. It describes the acceptance criteria for a new device and its accessories (optical grasping forceps and optical scissors) and states that testing was performed to confirm substantial equivalence to a predicate device. However, it does not provide the detailed results of a study to prove the device meets those acceptance criteria in the format requested, particularly for AI/machine learning aspects.
The document discusses non-clinical performance testing. It indicates that the device has met "pre-determined acceptance criteria" but does not define these criteria numerically or provide the raw or summarized performance data against them. There is no mention of AI or machine learning in this submission.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Design verification and validation activities included the following: Physical/functional/bench testing (cutting performance, gripping performance, ease of movement, visibility in the endoscope image)..." and later concludes that the device "meet all the pre-determined acceptance criteria of the testing performed to confirm substantial equivalence." However, the specific acceptance criteria (e.g., "cutting performance must be >= X cycles," or "grip strength must be >= Y N") and the actual measured device performance against these criteria are not provided in this document.
2. Sample sized 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 in the document. The document refers to "testing performed" but does not elaborate on the sample sizes for physical/functional/bench testing, biocompatibility, or reprocessing validation.
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 is not applicable as the document describes a physical medical device (cystoscopes/hysteroscopes and accessories) and refers to non-clinical performance testing, not studies involving human interpretation or AI using ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a physical medical device and non-clinical performance testing, not studies involving human interpretation or AI.
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 is not applicable. The document describes a physical medical device; there is no mention of AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The document describes a physical medical device; there is no mention of an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The document describes non-clinical performance testing of a physical medical device. The "ground truth" would be the engineering specifications and test standards for physical attributes like cutting force, grip strength, material properties, and reprocessing efficacy.
8. The sample size for the training set
This is not applicable. The document describes a physical medical device and non-clinical testing, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. See point 8.
Summary of available information from the document:
Here's a table based on the limited information that can be inferred regarding performance criteria and the claim of meeting them, acknowledging the absence of specific numerical acceptance criteria and performance data:
| Criterion Type | General Acceptance Criteria Mentioned (Not Specific Numerical) | Claimed Device Performance |
|---|---|---|
| Physical/Functional Performance | - Cutting performance | "Meet all the pre-determined acceptance criteria" (specifics not provided) |
| - Gripping performance | "Meet all the pre-determined acceptance criteria" (specifics not provided) | |
| - Ease of movement | "Meet all the pre-determined acceptance criteria" (specifics not provided) | |
| - Visibility in the endoscope image (for optical accessories) | "Meet all the pre-determined acceptance criteria" (specifics not provided) | |
| Biocompatibility | - Cytotoxicity | "Testing as per 10993-1:2018" (implies met relevant standards) |
| - Irritation | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| - Sensitization | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| - Acute systemic toxicity | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| - Material mediated pyrogenicity | "Testing as per 10993-1:2018" (implies met relevant standards) | |
| Reprocessing Validation | - Cleaning validation (AAMI TIR12:2010, AAMI TIR30:2011, FDA Guidance) | "Reprocessing validations for new accessories" (implies met relevant standards) |
| - High level disinfection validation (ASTM E 1837:96, FDA Guidance) | "Reprocessing validations for new accessories" (implies met relevant standards) | |
| - Sterilization validation (ISO 17664:2017, ANSI/AAMI/ISO 17665-1:2006, FDA Guidance) | "Reprocessing validations for new accessories" (implies met relevant standards) | |
| - Performance testing (visual inspection, ease of movement, cutting performance) after reprocessing | "Reprocessing validations for new accessories" (implies met relevant standards) |
Conclusion: The provided document is a 510(k) summary for a traditional medical device (cystoscopes/hysteroscopes and accessories) and details the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. It explicitly states that the device "meet all the pre-determined acceptance criteria" but does not provide the specific numerical acceptance criteria or the study results/data that would allow for a detailed fulfillment of your request regarding device performance against acceptance criteria. Crucially, it does not involve AI/machine learning, human readers, or structured ground truth beyond standard engineering/biocompatibility testing.
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October 8, 2020
Schoelly Fiberoptic GmbH % Pamela Papineau, RAC (US, EU, CAN) President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K201970
Trade/Device Name: Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) Regulation Number: 21 CFR$ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH, FAJ Dated: July 9, 2020 Received: July 15, 2020
Dear Pamela Papineau:
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201970
Device Name
Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a)
Indications for Use (Describe)
The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate.
The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
| 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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General Information
| Preparation date: | 10/08/2020 |
|---|---|
| Owner's Name: | Schoelly Fiberoptic GmbH (Registration: 8043903) |
| Address: | Robert-Bosch-Str. 1 – 379211 DenzlingenGermany |
| Telephone Number: | +49-7666-980-0 |
| Fax Number: | +49-7666-908-380 |
| Contact Person: | Dr. Sandra Baumann |
| Subject Device Name: | Schoelly Cystoscopes/Hysteroscopes and Accessories withadditional Optical Grasping Forceps (51-0575a) and OpticalScissor (51-0576a) |
| Common/Usual Name: | Cystoscopes/Hysteroscopes and Accessories |
| Classification Name: | Hysteroscope (And Accessories); Class II; 21 CFR 884.1690 |
| Product Codes: | HIH, FAJ |
| Predicate Device Name: | Schoelly Cystoscopes/Hysteroscopes and Accessories |
| Premarket Notification: | K150158, Schoelly Cystoscopes/Hysteroscopes and Accessories |
The predicate device has not been the subject of a design-related recall.
| Reference Device Name: | E-Line Cysto-Urethroscope and Accessories |
|---|---|
| Premarket Notification: | K1011496, Wolf E-Line Cysto-Urethroscope and Accessories |
Device Description
The Schoelly Cystoscope/Hysteroscope and Accessories comprise several models of rigid endoscopes as well as rigid endoscopic sheaths, obturators, and instrument bridges; the currently marketed system also includes a flexible grasping forceps. This Premarket Notification adds two rigid cystoscope/hysteroscope accessories (optical scissors and optical grasping forceps), both of which have been designed and are intended for use with the currently marketed Schoelly 4mm rigid cystoscope/hysteroscope and 20Fr sheath cleared in K150158. There are no changes to any of the other system components or accessories, nor are there any changes to the Schoelly Cystoscope/Hysteroscope and Accessories indications for use.
The optical scissors and optical grasping forceps accessories both consist of a rigid shaft with an inner lumen that accommodates the 4mm Schoelly Cystoscope/Hysteroscope. The outer diameter and the working length of both accessories are 4.6mm and 266mm, respectively. During application, the scissor or the forceps can be attached to the cystoscope via a simple mechanical locking located at the very proximal portion of the devices. The scissor or grasper is then inserted through a 20Fr Schoelly Cystoscope/Hysteroscope Sheath while being connected to the Schoelly Cystoscope/Hysteroscope. Another mechanical locking mechanism allows the user to lock all three coaxial components (scope, scissor/grasper accessory, and sheath) together. The scissor and grasper accessories incorporate a control handle. Operation of the control handle actuates the distal tip double action jaws via a pull wire mechanism. The optical scissor and grasper accessories are made entirely of stainless steel. The accessories are reusable instruments that are supplied nonsterile.
Indications for Use
The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate.
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The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
There are no changes to the indications for use due to the addition of two new accessories.
Substantial Equivalence / Comparison of Technical Characteristics with the Predicate Device The predicate device system consists of the Schoelly Cystoscopes and Accessories cleared in K150158. A detailed comparison of the subject and predicate device systems is provided in the substantial equivalence table below.
The Richard Wolf E-Line Cysto-Urethroscope and Accessories cleared in K011496 is cited as a reference device in this submission because it represents an example of an integrated rigid endoscope system that includes optical scissors and optical grasping forceps accessories with the same essential design as the new Schoelly optical accessories.
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| Proposed | Predicate Device | Similarities and Differences | |
|---|---|---|---|
| Attribute | Schoelly Cystoscopes/Hysteroscopes andAccessories(current submission) | Schoelly Cystoscopes/Hysteroscopes andAccessories(K150158) | |
| Common Name | Cystoscopes/Hysteroscopesand Accessories | Cystoscopes/Hysteroscopesand Accessories | Same |
| ClassificationName | Hysteroscopes and Accessories | Hysteroscopes and Accessories | Same |
| Device Class | Class II | Class II | Same |
| Regulation | 21 CFR 884.1690 | 21 CFR 884.1690 | Same |
| RegulationName | Hysteroscope and accessories | Hysteroscope and accessories | Same |
| Product Codes | HIH, FAJ | HIH, FAJ | Same |
Substantial Equivalence Comparison Table
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| Attribute | ProposedSchoelly Cystoscopes/Hysteroscopes andAccessories(current submission) | Predicate DeviceSchoelly Cystoscopes/Hysteroscopes andAccessories(K150158) | Similarities and Differences |
|---|---|---|---|
| Indicationsfor Use | The Schoelly Cystoscopes/Hysteroscopes andAccessories with additional Optical GraspingForceps (51-0575a) and Optical Scissor (51-0576a)are indicated to provide the user with the means forendoscopic diagnostic and therapeutic surgicalprocedures. Examples for the use of the devicesinclude the visualization and manipulation ofanatomy as the surgeon deems appropriate. TheSchoelly Cystoscopes/Hysteroscopes andAccessories with additional Optical GraspingForceps (51-0575a) and Optical Scissor (51-0576a)are intended to be used in general urological andgynecological surgery through a minimally invasiveapproach by utilizing natural orifices to access thesurgical site. | The Schoelly Cystoscopes/Hysteroscopes andAccessories are indicated to provide the user with themeans for endoscopic diagnostic and therapeuticsurgical procedures. Examples for the use of thedevices include the visualization and manipulation ofanatomy as the surgeon deems appropriate. TheSchoelly Cystoscopes/Hysteroscopes and Accessoriesare intended to be used in general urological andgynecological surgery through a minimally invasiveapproach by utilizing natural orifices to access thesurgical site. | Same |
| UseEnvironment | Hospital, clinic, medical office | Hospital, clinic, medical office | Same |
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| Attribute | ProposedSchoelly Cystoscopes/Hysteroscopes andAccessories(current submission) | Predicate DeviceSchoelly Cystoscopes/Hysteroscopes andAccessories(K150158) | Similarities and Differences |
|---|---|---|---|
| SystemComponents | Cystoscopes (rigid)Sheaths (rigid)Obturators (rigid)BridgesGrasping Forceps (flexible)Rigid optical grasperRigid optical scissor | Cystoscopes (rigid)Sheaths (rigid)Obturators (rigid)BridgesGrasping Forceps (flexible) | SimilarNo changes to and system componentscleared in K150158; add two rigidaccessories (optical scissors and opticalgrasping forceps) to be used with existingcystoscopes and sheaths.Reference device system cleared inK011496 provides an example of a rigidcystoscope system that includes rigidoptical scissors and grasping forcepsaccessories similar to those included inthis submission. |
| Proposed | Predicate Device | Similarities and Differences | |
| Attribute | Schoelly Cystoscopes/Hysteroscopes and | Schoelly Cystoscopes/Hysteroscopes and | |
| Accessories | Accessories | ||
| (current submission) | (K150158) | ||
| Principle ofOperation | Rigid cystoscope/hysteroscope and sheath allowsaccess to and visualization of anatomy accessed vianatural passages. Couplers/bridges can be used tolock system components together and allow accessto the anatomy via the sheath for irrigation andinsertion of instruments, e.g. graspers and scissors.Flexible grasping forceps allow for tissue andforeign body manipulation and can be inserted viathe couplers/bridges and the annular space betweenthe endoscope and the sheath. The rigid opticalscissor and grasper have a central lumen sized toaccept the endoscope; the scope and rigid accessoryare then inserted through the sheath and allow forcutting and manipulation of tissue and foreignbodies. | Rigid cystoscope/hysteroscope and sheath allowsaccess to and visualization of anatomy accessed vianatural passages. Couplers/bridges can be used tolock system components together and allow access tothe anatomy via the sheath for irrigation and insertionof instruments, e.g. graspers and scissors. Flexiblegrasping forceps allow for tissue and foreign bodymanipulation and can be inserted via thecouplers/bridges and the annular space between theendoscope and the sheath. | Similar;No changes to and system componentscleared in K150158; add two rigidaccessories (optical scissors and opticalgrasping forceps) to be used with existingcystoscopes and sheaths.Reference device system cleared inK011496 provides an example of a rigidcystoscope system that includes rigidoptical scissors and grasping forcepsaccessories similar to those included inthis submission. |
| ScopeDimensions | 2.9mm or 4mm OD x300-365mm working length | 2.9mm or 4mm OD x300-365mm working length | Same |
| Scope Optics | 0° - 70° Direction of ViewStandard & wide-angle FOV | 0° - 70° Direction of ViewStandard & wide-angle FOV | Same |
| SheathDimensions | 17-25Fr OD x260.5mm overall length | 17-25Fr OD x260.5mm overall length | Same |
| Obturator | Blind + visual obturator fits through sheath | Blind + visual obturator fits through sheath | Same |
| Bridges | Optic, instrument | Optic, instrument | Same |
| Attachments | Mechanical couplers lock components together | Mechanical couplers lock components together | Same |
| Attribute | ProposedSchoelly Cystoscopes/Hysteroscopes andAccessories(current submission) | Predicate DeviceSchoelly Cystoscopes/Hysteroscopes andAccessories(K150158) | Similarities and Differences |
| OtherAccessories | Grasping forceps (flexible). 7Fr OD x 400mmOptical scissors (rigid), 4.6mm OD x 302mmOptical grasper (rigid), 4.6mm OD x 302mm | Grasping forceps (flexible). 7Fr OD x 400mm | Similar;No changes to system components clearedin K150158; add two rigid accessories(optical scissors and optical graspingforceps) to be used with existingcystoscopes and sheaths.Reference device system cleared inK011496 provides an example of a rigidcystoscope system that includes rigidoptical scissors and grasping forcepsaccessories similar to those included inthis submission. |
| Patient-ContactingMaterials | Stainless steel, glass, epoxy,AuSn 80/20 brazing material, acetal | Stainless steel, glass, epoxy,AuSn 80/20 brazing material, acetal | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
| Single Use /Reusable | Reusable | Reusable | Same |
| ScopeReprocessing | Manual cleaning, high level disinfection, andsterilization | Manual cleaning, high level disinfection, andsterilization | Same; reprocessing validations for newaccessories |
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Differences between the proposed and the predicate devices do not raise different questions of safety and effectiveness.
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Non-clinical Performance Testing
The risks associated with the use of the new devices were found acceptable when evaluated in accordance with ISO 14971. Risks and benefits of the predicate device are the same as compared to the proposed ones.
Design verification and validation activities included the following:
- . Physical/functional/bench testing (cutting performance, gripping performance, ease of movement, visibility in the endoscope image)
- . Biocompatibility testing as per 10993-1:2018, including cytotoxicity, irritation, sensitization, acute systemic toxicity and material mediated pyrogenicity.
- Reprocessing validation, including: .
- Cleaning validation in accordance with AAMI TIR12:2010, and AAMI A TIR30:2011 , and FDA Guidance Processing Medical Devices in Healthcare Settings (dated: June 9, 2017),
- A High level disinfection validation in accordance with ASTM E 1837:96 (2007) and FDA Guidance Processing/Reprocessing Medical Devices in Healthcare Settings (dated: June 9, 2017),
- A Sterilization validation performed in accordance with ISO 17664:2017, ANSI/AAMI/ISO 17665-1:2006 and FDA Guidance Processing/Reprocessing Medical Devices in Healthcare Settings (dated: June 9, 2017), and
-
Performance testing, following reprocessing, including visual inspection, ease of movement and cutting performance.
Conclusion
The Schoelly Cystoscope/Hysteroscope and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) meet all the pre-determined acceptance criteria of the testing performed to confirm substantial equivalence to the predicate device
§ 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.