The Smith & Nephew Laparoscopes are indicated for use in illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder and Liver.

Smith & Nephew Bariatric Laparoscopes are indicated for illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, appendix, gallbladder and Liver.

Device Description

The proposed Smith+Nephew 4KO Direct View/Video Laparoscopes are surgical instruments used for illumination and visualization of surgical sites within articular cavities, body cavities, hollow organs and canals. A Laparoscope is a medical optical instrument that is intended for visualization of the insides of the human body by inserting the instrument into a natural or artificial opening.

The Laparoscopes are designed with various angle specifications for directions of view and working lengths for access to various locations. The design consist of a long tube containing a series of rod lenses that work to transfer the image of the patient's anatomy. through an associated visualization camera system, to a central monitor for clinical use in treatment.

The direct view scopes require attachment to an endocoupler and the VideoEndoscopes are attached to a Smith & Nephew C-Mount camera head.

Illumination is provided through a bundle of optical fibers internal to the Endoscope that transmits light from an external source to illuminate the image.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Smith & Nephew Laparoscopes. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the manner typically seen for novel AI/ML medical devices.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria, describe a study proving the device meets those criteria, or provide specifics on training/test sets, expert adjudication, or MRMC studies for an AI/ML device.

Here's why and what information is available:

Reasoning for Missing Information:

The submitted document pertains to a 510(k) submission for conventional medical devices (laparoscopes) and not an AI/ML-driven device. As such:

Acceptance Criteria & Performance Table: The document states the device met established performance specifications but does not list specific quantitative acceptance criteria for metrics like sensitivity, specificity, AUC, or other clinical performance measures that would be relevant for an AI/ML device. The performance testing mentioned is "Optical Performance, Leakage Integrity Testing, Electrical Safety Testing, Electromagnetic Compatibility," which are engineering/safety metrics, not clinical performance metrics.
Sample Size (Test Set) & Data Provenance: This information is not applicable in the context of this 510(k). The "test set" for this device would refer to testing of the physical device's engineering specifications, not a dataset of medical images or patient records.
Experts for Ground Truth & Qualifications: Not applicable. Ground truth, in the context of an AI/ML device, refers to definitive labels for data points (e.g., presence/absence of disease, exact lesion boundaries). For a laparoscope, the "ground truth" of its function is determined by its physical performance and safety.
Adjudication Method: Not applicable.
MRMC Study: Not applicable. MRMC studies are designed to assess the impact of AI assistance on human reader performance. This device is not an AI algorithm.
Standalone Performance: Not applicable. Standalone performance refers to the algorithm's performance without human intervention. This device is a physical instrument.
Type of Ground Truth: The "ground truth" for this device is its adherence to engineering specifications and safety standards, not clinical diagnostic accuracy.
Training Set Sample Size & Ground Truth Establishment (for Training): Not applicable, as this is not an AI/ML device that undergoes a training phase with a dataset.

Information Available in the Document Related to "Performance":

The document mentions "Performance Testing" to demonstrate that the devices meet "established performance specifications."

Type of Performance Testing:
- Optical Performance
- Leakage Integrity Testing
- Electrical Safety Testing
- Electromagnetic Compatibility
Conclusion: "The Smith & Nephew Laparoscopes met all specified criteria and did not raise new safety or effectiveness questions."

In summary, the provided text describes a regulatory submission for physical medical devices (laparoscopes) and not an AI/ML-driven diagnostic or therapeutic system. Therefore, the detailed requirements for describing AI/ML device acceptance criteria and study designs are not present in this document.

Summary

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July 17, 2020

Smith & Nephew Inc., Endoscopy Division Janice Haselton Principal Regulatory Affairs Specialist 150 Minuteman Rd Andover, Massachusetts 01810

Re: K201198

Trade/Device Name: Smith & Nephew Laparoscopes (4KO, Autoclavable), Smith & Nephew Bariactric Laparoscopes (4KO, Autoclavable) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 20, 2020 Received: May 21, 2020

Dear Janice Haselton:

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

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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 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-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201198

Device Name Smith & Nephew Laparoscopes

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K201198

Device Name Smith & Nephew Bariatric Laparoscopes

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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th & Nephew. Inc. 50 Minuteman Road Andover, MA 01810

T + 1 978 749 1000 T: + 1 800 343 8386 (USA toll free) www.smith-nephew.com

K201198

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew: Smith & Nephew Endoscopes (Laparoscopes and Bariatric Laparoscope)

Date Prepared: July 16, 2020

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road, Andover MA. 01810

B. Company Contact:

Janice Haselton Principal Regulatory Affairs Specialist T 978-749-1494

C. Device Name

Trade Name: Smith & Nephew Endoscopes Common Name: Laparoscopes Classification Name: Endoscopes and Accessories per 876.1500 Regulatory class: II Product Code: GCJ

D. Predicate Devices

The Smith & Nephew Laparoscopes and Bariatric Laparoscopes are substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:

Henke Sass Wolf Laparoscopes and Laparoscopes cleared in K941541 (Laparoscopes) and K050163 (Bariatric Laparoscopes).

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K201198

E. Device Description

The direct view scopes require attachment to an endocoupler and the VideoEndoscopes are attached to a Smith & Nephew C-Mount camera head.

Illumination is provided through a bundle of optical fibers internal to the Endoscope that transmits light from an external source to illuminate the image.

F. Intended Use/Indications for Use

Intended Use

The Smith & Nephew Laparoscopes are intended to be used in general laparoscopic surgery for access to internal structures.

Indications for Use

Smith & Nephew Laparoscopes are indicated for use in for illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and Liver.

Bariatric Laparoscopes

Intended Use

Smith & Nephew Bariatric Laparoscopes are intended to be used in general laparoscopic surgery for access to internal structures in morbidly obese segments of the patient population.

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Indications for Use

G. Comparison of Technological Characteristics

The S&N Laparoscopes maintain the following similarities to what was previously cleared in K941541 (Laparoscopes) and K050163 (Bariatric Laparoscopes). In that:

· The proposed and predicate devices have similar indications for use/intended use.
· Both the proposed and predicate devices utilize the same principle of operation and incorporate the same basic design
· Incorporate the same materials

The difference in the new Smith+Nephew Endoscopes as compared to the predicate devices are:

· The new Smith+Nephew 4KO Endoscopes have an improved optical design in order to provide 4KO capabilities for sharper visualization compared to the predicate HD scopes.
· The new Smith+Nephew 4KO Endoscopes have an updated focusing mechanism design with similar shape and smaller focus ring size compared to the predicate HD Laparoscopes.

The differences that the Smith & Nephew Laparoscopes have met the performance specifications and therefore are substantially equivalent to the predicate device cleared in K941514 and K050163.

H. Performance Testing

Performance Testing-Bench

The following testing was performed on the Laparoscopes to demonstrate that they meet the established performance specifications and therefore, are substantially equivalent to the predicate device cleared in K941541 (Laparoscopes) and K050163 (Bariatric Laparoscopes).

Optical Performance
Leakage Integrity Testing ●
Electrical Safety Testing

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Electromagnetic_Compatibility ●

I. Conclusion

The Smith & Nephew Laparoscopes met all specified criteria and did not raise new safety or effectiveness questions. The substantial equivalence of the modified devices is based on similar indications for use, same principle of operation and same basic design. Based on the similarities to the predicate devices and performance data, the Smith+Nephew Laparoscopes are substantial equivalent to its predicates K941541 and K050163.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.