(72 days)
Not Found
No
The description focuses on mechanical resection and electrical ablation/hemostasis, with no mention of AI or ML.
Yes
The device is used in arthroscopic procedures for resection of soft tissue and bone, ablation of soft tissue, and hemostasis of blood vessels, all of which are direct medical interventions aimed at treating a condition.
No
The "Intended Use / Indications for Use" states the device is used for resection, ablation, and hemostasis during arthroscopic procedures, which are interventional treatments rather than diagnostic activities.
No
The device description explicitly states it is a combination of a mechanical shaver blade and a monopolar electrode, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection of soft tissue and bone, ablation of soft tissue and hemostasis of blood vessels" in "arthroscopic procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description confirms it's a combination of a shaver blade and an electrode, designed for mechanical resection and ablation/hemostasis. This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing biological samples to provide diagnostic information. This device is a surgical tool used for treatment and manipulation of tissue in vivo.
N/A
Intended Use / Indications for Use
The Resection Ablator is intended to be used in arthroscopic procedures for resection of soft tissue and bone, ablation of soft tissue and hemostasis of blood vessels.
Product codes (comma separated list FDA assigned to the subject device)
GEI, GEY, HRX
Device Description
The Resection Ablator is a combination of a Linvatec arthroscopic shaver blade and a Linvatec UltrAblator™ monopolar electrode. The product configuration combines the mechanical resection of a shaver blade and the ablation and hemostasis functions of an electrode. The Resection Ablator is supplied sterile, single use.
This submission describes a modification to the existing Trident Resection Ablator that received marketing clearance under 510(k)# K002088 on March 6, 2001.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 has been conducted to show that the modifications to the Trident Resection Ablator do not raise any new questions regarding safety and effectiveness.
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
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of In accordance with the required. Sales Corporation is hereby submitting the 1990 and 21 CFR 007752/ Envilles for the Resection Ablator 510(k) Number K013117.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura D. Seneff, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
Device Name C.
Trade Name: Resection Ablator
Common Name: Electrode
Electrosurgical Cutting and Coagulation Classification Names: Device and Accessories Surgical Instrument Motors and Accessories/Attachments
Class II Proposed Class: GEI, Electrosurgical Electrode Product Codes: GEY, Surgical Instrument Motors and Accessories/Attachments
1
Summary of Safety and Effectiveness Resection Ablator 510(k) # K013117 9/17/01 Page 2 of 2
Predicate/Legally Marketed Devices D.
510(k) #K002088 Trident™ Resection Ablator Linvatec Corporation
Advantage Drive System Linvatec Corporation
510(k) #K002523
Device Description E.
The Resection Ablator is a combination of a Linvatec arthroscopic shaver blade and a Linvatec UltrAblator™ monopolar electrode. The product configuration combines the mechanical resection of a shaver blade and the ablation and hemostasis functions of an electrode. The Resection Ablator is supplied sterile, single use.
This submission describes a modification to the existing Trident Resection Ablator that received marketing clearance under 510(k)# K002088 on March 6, 2001.
F. Intended Use
The Resection Ablator is intended to be used in arthroscopic procedures for resection of soft tissue and bone, ablation of soft tissue and hemostasis of blood vessels.
Substantial Equivalence G.
The Resection Ablator is substantially equivalent in design, technology and intended use to Linvatec's existing Trident Resection Ablator and arthroscopic shaver blades used with the Advantage Drive System. Performance testing has been conducted to show that the modifications to the Trident Resection Ablator do not raise any new questions regarding safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2001
Ms. Laura D. Seneff, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Re: K013117
Trade/Device Name: Resection Ablator Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: September 17, 2001 Received: September 18, 2001
Dear Ms. Seneff:
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.
3
Page 2 - Ms. Laura D. Seneff, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogen maing of substantial equivalence of your device to a legally prematicated 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 If you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fart 007.10 for his mally, for questions on the promotion and advertising of Compliance at (301) 594-1057. The Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation chities, "Thisoranang of esponsibilities under the Act may be obtained from the Other general information on your securitional 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/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
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
4
11/7/01
510(k) Number: K013117
Device Name: Resection Ablator
The Resection Ablator is intended to be used in arthroscopic The Resection Ablator 15 incolnetter and bone, ablation of soft tissue and hemostasis of blood vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use Prescription Use كل OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Susan Walker
(Division Sign-Off) Division of General. Restorative and Neurological bevices
510(k) Number_ K613117