(74 days)
No
The description focuses on optical visualization and illumination, with no mention of AI/ML for image analysis or other functions.
No.
The device is described as a surgical instrument used for "illumination and visualization to surgical sites" and "visualization of the insides of the human body," indicating it is for diagnostic or viewing purposes, not for directly treating a condition.
No.
The device is used for "illumination and visualization to surgical sites within the body" for surgical procedures, it is not used to diagnose a medical condition.
No
The device description clearly outlines physical components like a long tube, rod lenses, optical fibers, and the need for attachment to camera heads and endocouplers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "illumination and visualization to surgical sites within the body." This is a direct visualization tool used during surgical procedures.
- Device Description: The description reinforces this by stating it's a "surgical instrument used for illumination and visualization" and describes its function in providing an image of the inside of the body for clinical use in treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool for direct observation during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
articular cavities, body cavities, hollow organs and canals, abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Electromagnetic_Compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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)
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.
| 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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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Indications for Use
510(k) Number (if known) K201198
Device Name Smith & Nephew Bariatric Laparoscopes
Indications for Use (Describe)
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, and examination of the abdominal cavity, appendix, gallbladder and Liver.
| 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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
4
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).
5
K201198
E. 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.
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.
6
Indications for Use
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.
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
7
- 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.