(24 days)
Not Found
No
The description focuses on the optical and mechanical aspects of a rigid endoscope for visualization, with no mention of AI/ML terms, image processing beyond basic visualization, or data processing/analysis capabilities.
No.
The device is used for illumination and visualization during diagnostic and operative procedures, not for treatment or therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "Diagnostic and operative arthroscopic procedures" and "Endoscopic examination and treatment of the nasal cavities and nasal pharynx." The term "Diagnostic" and "examination" directly imply a diagnostic purpose.
No
The device description explicitly states it is a "line of rigid Arthroscopes/ENT Endoscopes" and describes its physical components and function as a reusable device inserted into the body for illumination and visualization. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They perform tests outside the body.
- Device Function: The description clearly states that this device is a rigid endoscope used for direct visualization and illumination within the human body (joint spaces, nasal cavities, etc.). It is inserted into the body to allow a healthcare professional to see inside.
- Intended Use: The intended use is for diagnostic and operative procedures within the body, not for testing samples taken from the body.
Therefore, this device falls under the category of a surgical or diagnostic instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Smith & Nephew 4 mm diameter rigid Arthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
Smith & Nephew Arthroscopes are reusable devices and are sterilized using a variety of sterilization methods. Arthroscopes are used by being inserted into an artificial opening of the human body to provide illumination and visualization of a joint space. The optical design of the standard arthroscope consists of the objective lens which creates the image and transfers it through the optical train by means of identical relays that maintain the image quality with very little degradation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Joint space, nasal cavities, nasal pharynx, hip joint
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)
All verification data demonstrates that the device is safe and effective and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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.
0
007 1 5 2007
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 Arthroscope
Date Prepared:
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA
B. Company Contact
Janice Haselton Sr. Regulatory Affairs Specialist Phone: (978)749-1494 Fax: (978)749-1443
C. Device Name
| Trade Name: | Smith & Nephew Arthroscope |
|---|---|
| Common Name: | Arthroscope |
| Classification Name: | Arthroscope |
D. Predicate Devices
The current line of Smith & Nephew Arthroscopes serves as the predicate device for this submission (K043395).
E. Description of Device
Smith & Nephew Arthroscopes are reusable devices and are sterilized using a variety of sterilization methods. Arthroscopes are used by being inserted into an artificial opening of the human body to provide illumination and visualization of a joint space. The optical design of the standard arthroscope consists of the objective lens which creates the image and transfers it through the optical train by means of identical relays that maintain the image quality with very little degradation.
F. Intended Use
The Smith & Nephew line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.
Smith & Nephew, Inc. Smith & Neohew Arthroscopes Page 32 of 59
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In addition, the Smith & Nephew 4 mm diameter rigid Arthroscopes/ENT Endoscopes 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 Smith & Nephew Arthroscopes have the same Indications for Use as the predicate device, utilizes the same operating principle, incorporates the same basic design, and are manufactured under a Quality System.
H. Summary Performance Data
All verification data demonstrates that the device is safe and effective and performs as intended.
Smith & Nephew, Inc. Smith & Nephew Arthroscopes Page 33 of 59
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · (USA)" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2007
Smith & Nephew, Inc. % Ms. Janice Haselton Sr. Regulatory Affairs Specialist Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K072675
Trade/Device Name: Smith & Nephew Arthroscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: September 20, 2007 Received: September 21, 2007
Dear Ms. 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set
3
Page 2 - Ms. Janice Haselton
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
F.2
Mark N. Melkerson
Director
DES
0,2
101001
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072675
Device Name: Smith & Nephew Arthroscope
Indications For Use: The line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in: Diagnostic and operative arthroscopic procedures. Endoscopic examination and treatment of the nasal cavities and nasal pharynx.
In addition, the Smith & Nephew 4 mm diameter rigid Arthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in: The removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number K072626
Smith & Nephew, Inc. Smith & Nephew Arthroscopes Page 15 of 59