(33 days)
Not Found
No
The summary describes a standard video endoscope with mechanical focus and does not mention any AI/ML features or image processing capabilities beyond basic visualization.
No
The device is used for illumination and visualization during diagnostic and operative procedures, not for direct therapeutic treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "illumination and visualization in diagnostic and operative arthroscopic procedures" and "endoscopic examination and treatment of the nasal cavities and nasal pharynx." The term "diagnostic" directly implies its use in diagnosing conditions.
No
The device description explicitly states it is a "reusable VideoArthroscope" and mentions physical characteristics like "diameters, lengths, and with direction of view," 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 clearly states that the device is used for "illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx." This describes a device used directly on or within the body for visualization and surgical procedures.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description of the device as a "reusable VideoArthroscope" with various diameters, lengths, and directions of view further supports its use for direct visualization within the body.
The information provided does not mention any testing of samples taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Smith & Nephew line of rigid Multimode VideoArthroscopes/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 4.0mm diameter rigid Video Athroscopes/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, EOB
Device Description
The Smith & Nephew VideoArthroscope is a reusable VideoArthroscope. The proposed device is available in a variety if diameters, lengths, and with direction of view ranging from 0° to 110° and incorporates a mechanical focus mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (implied by arthroscopic procedures), 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 and validation 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
K 043395
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 VideoArthroscope
Date Prepared: December 7, 2004
- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA
B. Company Contact
Kathleen Burns Regulatory Affairs Associate Phone: (978)474-6301 (978)749-1443 Fax:
C. Device Name
Smith & Nephew VideoArthroscope Trade Name: Common Name: Arthroscope Classification Name: Arthroscope
D. Predicate Devices
The current Smith & Nephew VideoArthroscope serves as the predicate device for this submission (K971253).
E. Description of Device
The Smith & Nephew VideoArthroscope is a reusable VideoArthroscope. The proposed device is available in a variety if diameters, lengths, and with direction of view ranging from 0° to 110° and incorporates a mechanical focus mechanism.
F. Intended Use
The Smith & Nephew line of rigid Multimode VideoArthroscopes/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 4.0mm diameter rigid Video Athroscopes/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.
1
G. Comparison of Technological Characteristics
The Smith & Nephew VideoArthroscope has the same Indications for Use as the predicate device, utilizes the same operating principle, incorporates the same basic design, and is manufactured under a Quality System.
H. Summary Performance Data
All verification and validation data demonstrates that the device is safe and effective and performs as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2005
Ms. Kathleen Burns Regulatory Affairs Associate Smith & Nephew, Inc. 150 Minuteman, Road Andover, Massachusetts 01810
Re: K043395
Trade/Device Name: Smith & Nephew VideoArthroscope Regulation Number: 21 CFR 888.1100, 21 CFR 874.4760 Regulation Name: Arthroscope, Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: HRX, EOB Dated: December 8, 2004 Received: December 10, 2004
Dear Ms. Burns:
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 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.
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Page 2 - Ms. Kathleen Burns
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 your 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director 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
Device Name: Smith & Nephew VideoArthroscope
Indications For Use: The Smith & Nephew VideoArthroscopes/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 VideoArthroscopes/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 X (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)
Neil R. Ogden
(Division Sign-Off) for
Division of General, Restora and Neurological Devices
510(k) Number K043395