(175 days)
Not Found
No
The document describes a mechanical and electrical surgical tool with modifications to its physical components and materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended for "resection of soft tissue, ablation of soft tissue and hemostasis of blood vessels," which are therapeutic actions to treat medical conditions.
No
The device description indicates its purpose is for resection, ablation, and hemostasis of soft tissue during arthroscopic procedures, which are therapeutic and not diagnostic functions.
No
The device description clearly states it is a combination of a shaver blade and a monopolar electrode, which are physical 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, ablation of soft tissue and hemostasis of blood vessels" in "arthroscopic procedures." These are surgical procedures performed directly on the body, not tests performed on samples taken from the body.
- Device Description: The description details a surgical instrument combining a shaver blade and an electrode for mechanical and electrical tissue manipulation. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The Resection Ablator is intended to be used in arthroscopic procedures for resection of soft tissue, ablation of soft tissue and hemostasis of blood vessels.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HRX
Device Description
The Resection Ablator is a combination of a Linvatec arthroscopic shaver blade and a Linvatec UltrAblator® monopolar electrode. The product blado and a Lifratus s the mechanical resection of a shaver blade and the oblation and hemostasis functions of an electrode. The Resection Ablator is supplied sterile, single use.
This submission describes the next generation of the Resection Ablator rnie oubline. The shaver blade portion of the device has been changed, as well as materials of the ceramic tip, insulation coating and electrode. The ceramic tip and electrode strip configuration have also been changed to extend nearer the distal tip.
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 issues 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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
January 7, 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Resection Ablator, 510(k) Number K013369 .
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Laura D. Seneff, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
Trade Name: Resection Ablator
Common Name: Electrosurgical Electrode
Classification Names: Electrosurgical cutting and coagulation device and accessories, 21 CFR 878.4400
Proposed Class/Device: Class II Product Code GEI
1
Summary of Safety and Effectiveness Resection Ablator 510(k)# K013369 January 7, 2002 Page 2 of 2
Predicate/Legally Marketed Devices D.
Trident™ Resection Ablator Linvatec Corporation
510(k) #K002088
Device Description ய்
The Resection Ablator is a combination of a Linvatec arthroscopic shaver blade and a Linvatec UltrAblator® monopolar electrode. The product blado and a Lifratus s the mechanical resection of a shaver blade and the oblation and hemostasis functions of an electrode. The Resection Ablator is supplied sterile, single use.
This submission describes the next generation of the Resection Ablator rnie oubline. The shaver blade portion of the device has been changed, as well as materials of the ceramic tip, insulation coating and electrode. The ceramic tip and electrode strip configuration have also been changed to extend nearer the distal tip.
ட் Intended Use
The Resection Ablator is intended to be used in arthroscopic procedures for resection of soft tissue, 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. Performance testing has been conducted to show that the modifications to the Trident Resection Ablator do not raise any new issues regarding safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with the negative space forming a human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura Seneff Manager Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K013369
Trade/Device Name: Resection Ablator Regulation Number: 878.4400 and 888.1100 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories and Arthroscope Regulatory Class: II Product Code: GEI and HRX Dated: January 7, 2002 Received: January 9, 2002
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.
APR = 4 2002
3
Page 2 - Ms. Laura Seneff
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
CorCelia 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
January 7, 2002
510(k) Number (if known):_K013369
Device Name: Resection Ablator
Indications for Use:
The Resection Ablator is intended to be used in arthroscopic procedures for resection The Resection Ablator is Interiabulation to be acconsists 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_ OR Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Muriam C. Provost
Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K013369