(51 days)
Not Found
No
The 510(k) summary describes a mechanical surgical instrument and makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is used for surgical resection of tissue, which directly treats a medical condition.
No.
The device description and intended use indicate it is an endoscopic surgery blade for resecting and removing tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an instrument consisting of concentric tubes and various tip designs, driven by a motor, and used to resect and remove tissue. This describes a physical, hardware-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is an endoscopic surgery blade used in vivo (inside the body) to resect and remove tissue during surgical procedures. Its function is to physically cut and remove tissue, not to analyze biological samples for diagnostic purposes.
The description clearly indicates its use in surgical procedures within articular cavities, which is a therapeutic and surgical function, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
Indicated for use during endoscopic resection of soft and osseous tissue in various large and small articular cavities. These blades are for limited reuse. The actual number of reuses will be dependant on proper care and use of the healthcare facilities.
Product codes
HRX
Device Description
Limited reuse instrument consisting of several concentric tubes and various tip designs. The blades are used to resect and remove tissue endoscopically. The inner blade is driven by a motor. Tissue is removed by suction through the inner diameter of the inner blade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various large and small articular cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
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)
The modification to the devices referenced in this 510(k) notification as compared to the predicate devices is the addition of a validated sterilization method and inclusion of test data showing that burr devices will meet all performance and safety standards when run at 8000 rpm.
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
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
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 508-749-1000 Telefax: 508-749-1599
Smith = Nephew
97i676
JUN 27 1997
510(k) Summarv Smith & Nephew, Inc., Endosopy Division Limited Reuse Endoscopic Surgery Blades
Substantial Equivalence :
The Smith & Nephew, Inc., Endosopy Division Limite Reuse Endoscopic Surgery Blades were originaly determined to be substantially equivalent to predicate devices under 510(k) K955914.
Predicate Device :
The modification to the devices referenced in this 510(k) notification as compared to the predicate devices is the addition of a validated sterilization method and inclusion of test data showing that burr devices will meet all performance and safety standards when run at 8000 rpm.
Summary of Device Function :
Limited reuse instrument consisting of several concentric tubes and various tip designs. The blades are used to resect and remove tissue endoscopically. The inner blade is driven by a motor. Tissue is removed by suction through the inner diameter of the inner blade.
Intended Use of Device :
Indicated for use during endoscopic resection of soft and osseous tissue in various large and small articular cavities. These blades are for limited reuse. The actual number of reuses will be dependant on proper care and use of the healthcare facilities.
Comparison of Technological Characteristics of Predicate Device :
The design and function of the items refered to in this 510(k) notification are identical to those listed in the previous limited reuse endoscopic surgery blade 510(k)s submitted by The Smith & Nephew, Inc., Endosopy Division.
Elizabeth A. Ryan
Regulatory Affairs
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 1997
Ms. Elizabeth A. Ryan Regulatory Affairs Smith & Nephew, Inc ... Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810
Re: K971676 Trade Name: Limited Reuse Endoscopic Blades Regulatory Class: II
Product Code: HRX Dated: May 6, 1997 Received: May 7, 1997
Dear Ms. Ryan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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, Farts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the
2
Page 2 - Ms. Elizabeth A. Ryan
Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Stephen Rhode
A Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number: K971676
Device Name : Limited Reuse Endoscopic Surgery Blades
Indications for Use :
The Smith & Nephew, Inc., Endoscopy Division Limited Reuse Endoscopic Surgery Blades as indicated for use during endoscopic resection of soft and osseous tissue in various large and small articular cavities. These blades are for limited reuse. The actual number of reuses will be dependant on proper care and use of the blade by healthcare facilities.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-the-Counter
(Optional Format 1-2-96)
Huston Oliveles
(Division Sign-Off) Division of General Restoral Restoration . Devices 510(k) Number_