(142 days)
Not Found
No
The summary describes a standard electrosurgical instrument and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
Yes
The device is used for cutting, dissecting, and cauterizing soft tissue, which are actions performed to treat or manage a medical condition.
No
The device is described as a monopolar electrosurgical instrument used for cutting, dissecting, and cauterizing soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "monopolar electrosurgical instrument," which is a hardware device used for cutting, dissecting, and cauterizing tissue. There is no mention of software as the primary or sole component.
Based on the provided information, the Colorado MicroDissection Needle® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. They are used in vitro (outside the body) to diagnose diseases or other conditions.
- The Colorado MicroDissection Needle® is a surgical instrument used in vivo (inside the body). Its intended use is for cutting, dissecting, and cauterizing soft tissue directly on a patient.
The description clearly states it's a "monopolar electrosurgical instrument used for precision soft tissue dissection," and lists surgical procedures like tonsillectomy and blepharoplasty as examples of its use. This is the opposite of what an IVD device does.
N/A
Intended Use / Indications for Use
The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectorny and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; Not intended for use in the central nervous system or in the central circulatory system.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 2 5 2004
| 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: | |
|---|---|
| Stryker Leibinger Colorado MicroDissection Needle® | |
| General Information | |
| Proprietary Name: | Stryker Leibinger Colorado MicroDissection Needle® |
| Common Name: | Electrode, Electrosurgical |
| Proposed Regulatory Class: | Class II |
| Device Classification: | GEI |
| 878.4400, Electrosurgical Electrode | |
| Submitter: | Stryker Leibinger |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 269-323-4226 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 9616696 |
| Contact Person: | Wade T. Rutkoskie |
| Associate Manager RA QA | |
| Phone: 269-323-4226 | |
| Fax: 269-323-4215 |
Intended Use
The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectorny and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.
Substantial Equivalence
EQUIVALENT PRODUCTS:
The Stryker Colorado MicroDissection Needle is equivalent to the previous version of the product cleared under K000348, and the product manufactured by Colorado Biomedical, Inc. and cleared with K881763. Equivalent product information is found in Appendix 3.
Wade T. Kuttorffie
Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments Leibinger Division
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract bird in flight, composed of three curved lines above a wavy base. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2004
Mr. Wade T. Rutkoskie Associate Manager RA, QA Stryker Leibinger 4100 East Milham Avenuc Kalamazoo, Michigan 49001
Re: K033232
Trade/Device Name: Strykcr Leibinger Colorado MicroDisscction Needle® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 9, 2003 Received: December 10, 2003
Dear Mr. Rutkoskic:
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 Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the l'ederal 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 mar be bained 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 or mr) vith 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 Or R ratt 80 7) at regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Wade T. Rutkoskie
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
L. Mark A. Melkersson
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
3
Pagc 1 of 1
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Colorado MicroDissection Needle®
Intended Use:
The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectorny and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K033232 |
| Prescription Use (per 21 CFR 801.109) | |
|---|---|
| or | Over-The-Counter Use |
(Optional Format 1-2-96)