(60 days)
The Smith+Nephew Arthroscopes is indicated to provide illumination and visualization in:
· Diagnostic and Operative arthroscopic procedures for the hip, knee, shoulder, wrist, ankle, elbow, and feet.
In addition, Smith+Nephew 4 mm diameter rigid athroscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
The proposed Smith+Nephew 4KO Direct View/Video Arthroscopes are a line extension to the previously cleared K971253 and are surgical instruments used for illumination and visualization of surgical sites within articular cavities, body cavities, hollow organs and canals.
The Arthroscopes are designed with various angle specifications for directions of view and working lengths for access to various locations. The Arthroscopes are shipped non-sterile and must be cleaned, inspected and sterilized prior to each use. Both designs 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.
This inquiry pertains to a 510(k) premarket notification for the "Smith+Nephew Arthroscopes" (K201349). The provided documentation describes a medical device, specifically an arthroscope, which is a type of endoscope used for visualization during diagnostic and operative arthroscopic procedures.
The information provided does not describe an AI/ML powered device, nor does it detail a study that proves the device meets specific acceptance criteria in the manner one would typically expect for an AI/ML product. The document instead focuses on demonstrating substantial equivalence to a predicate device through performance testing of the physical arthroscope.
Therefore, many of the requested fields cannot be filled as they are explicitly related to AI/ML device testing and evaluation.
Here's a breakdown of the available information and why other fields cannot be completed:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Optical Performance | Met performance specifications |
| Leakage Integrity | Met performance specifications |
| Electrical Safety Testing | Met performance specifications |
| Electromagnetic Compatibility | Met performance specifications |
| Cleaning Validation | Met all acceptance criteria per AAMI TIR 12:2010 and AAMI TIR 30:2011 |
| Sterilization Validation | Met all acceptance criteria per AAMI TIR 12:2010 and AAMI TIR 30:2011 |
| Biocompatibility | Met all acceptance criteria per ISO 10993-1:2018 |
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 "Performance Testing" in general terms for the physical device but does not specify sample sizes for these tests, nor the origin or nature of the data (e.g., patient data, in-vitro testing).
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 as the device is a physical arthroscope, not an AI/ML diagnostic or image analysis tool requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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 as this is not an AI/ML device, and no MRMC study is detailed for its comparison or human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for the reasons stated above. The "ground truth" for a physical arthroscope's performance would relate to physical specifications and functional tests, not clinical diagnostic ground truth.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" or associated ground truth establishment process.
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July 20, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew Kathleen Solomon Principal Regulatory Affairs Specialist 150 Minuteman Rd Andover, Massachusetts 01810
Re: K201349
Trade/Device Name: Smith+Nephew Arthroscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: May 20, 2020 Received: May 21, 2020
Dear Ms. Solomon:
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.
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
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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,
Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K201349
Device Name Smith+Nephew Arthroscopes
Indications for Use (Describe)
The Smith+Nephew Arthroscopes is indicated to provide illumination and visualization in:
· Diagnostic and Operative arthroscopic procedures for the hip, knee, shoulder, wrist, ankle, elbow, and feet.
In addition, Smith+Nephew 4 mm diameter rigid athroscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
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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T: + 1 978 749 1000 T: + 1 800 343 8386 (USA toll free) www.smith-nephew.com
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 Arthroscopes
Date Prepared: July 20, 2020
A. Submitter's Name:
Smith+Nephew, Inc., Endoscopy Division
150 Minuteman Road, Andover MA. 01810
B. Company Contact:
Kathleen Solomon Principal Regulatory Affairs Specialist T 978-749-1605
C. Device Name
Trade Name: Smith+Nephew Arthroscopes Common Name: Arthroscopes Classification Name: Arthroscopes per 888.1100 Regulatory class: II Product Code: HRX
D. Predicate Devices
The Smith+Nephew Arthroscope are substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution: Henke Sass Wolf Arthroscopes, K080560.
Description of Device ن
The proposed Smith+Nephew 4KO Direct View/Video Arthroscopes are a line extension to the previously cleared K971253 and are surgical instruments used for illumination and visualization of surgical sites within articular cavities, body cavities, hollow organs and canals.
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The Arthroscopes are designed with various angle specifications for directions of view and working lengths for access to various locations. The Arthroscopes are shipped non-sterile and must be cleaned, inspected and sterilized prior to each use. Both designs 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
The Smith+Nephew Arthroscopes are intended to provide illumination and visualization in diagnostic and operative arthroscopic procedures.
Indication for Use:
The Smith+Nephew Arthroscopes is indicated to provide illumination and visualization in:
- Diagnostic and Operative arthroscopic procedures for the hip, knee, shoulder, wrist, ankle, elbow, and feet.
In addition, Smith+Nephew 4 mm diameter rigid arthroscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
G. Comparison of Technological Characteristics
The S+N Arthroscopes maintain the following similarities as the predicate devices cleared in K080560. 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 Arthroscopes as compared to the predicate devices are:
- . The new Smith+Nephew 4KO Arthroscopes have an improved optical design in order to provide 4K resolution capabilities for sharper visualization compared to the predicate HD.
- The new Smith + Nephew VideoArthroscopes have an updated focusing mechanism design with similar shape and smaller focus ring size comparing to HD endoscopes
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The differences between the proposed and predicate devices do not constitute a new Intended use, there are no major differences in technological characteristics and does not introduce new risks or questions of safety or effectiveness.
H. Performance Data
Performance Testing demonstrates that the Smith+Nephew Arthroscopes have met the performance specifications:
- Optical Performance
- Leakage Integrity
- · Electrical Safety Testing
- Electromagnetic Compatibility
- · Cleaning Validation
- Sterilization Validation
- · Biocompatibility
Smith+Nephew validated cleaning and sterilization of the Arthroscopes against the requirement of AAMI TIR 12:2010 and AAMI TIR 30:2011 and all acceptance criteria were met. Biocompatibility assessment of the Arthroscopes against the requirements per ISO 10993-1:2018 and all acceptance criteria were met.
Therefore, the Arthroscopes are considered substantially equivalent the currently marketed predicate.
G. Conclusion:
The Smith+Nephew Arthroscopes met all specified criteria and did not raise new safety or effectiveness questions. The substantial equivalence of the modified device is based on the same fundamental technology. Based on the similarities to the predicate and the performance data, the S+N Arthroscopes are considered substantially equivalent to the predicate K080560.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.