(199 days)
Not Found
No
The summary describes a standard electrosurgical device for cutting and coagulation, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the hardware components and intended use.
Yes.
The device's intended use is to ablate tissue and/or cauterize in joints like ankles, knees, hips, wrists, elbows, and shoulders, indicating it performs a therapeutic function to treat medical conditions.
No
Explanation: The device is described as a "cutting and coagulation accessory" intended to "ablate tissue and/or cauterize," indicating a therapeutic rather than diagnostic function. It is used in surgical procedures within joints.
No
The device description clearly outlines hardware components including a system controller, power source, cables, foot-pedal, and a wand, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states the device is used to "ablate tissue and/or cauterize" within joints during surgery. This is an in vivo (within the living body) procedure, not an in vitro test.
- Intended Use: The intended use is for surgical procedures in joints, not for analyzing biological samples.
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders. They are supplied sterile.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GEI
Device Description
The cutting and coagulation system consists of a system controller that is connected to a power source. Two cables extend from the system controller, one to a foot-pedal to allow the operator to control the device; the other cable leads to the wand portion, which functions in the surgical site. The wand is the accessory for which MIT has developed the reprocessing technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joints such as, ankles, knees, hips, wrist, elbow, and shoulders.
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)
Not Found
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.
Mitek (K974022) or Arthrocare Wands (K962321)
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
012640
Medical Instruments Technology, Inc's. Reprocessed Electrosurgical Wand Premarket Notification
Medical Instruments Technology™
FEB 2 8 2002
Quality Reprocessing and Surgical Cost Containmen
Section 12: 510k Summary
Name of Submitter
Medical Instruments Technology, Inc. 385 North 3050 East Saint George, UT 84790 Tel: (435) 674-4010 Fax: (435) 674-9819
Contact persons
Tom Haueter, RA/QA Manager Crystal Batcabe, Assistant RA/QA Manager
Summary Prepared August 10, 2001
Device Name and Classification
Common Name: Electrosurgical Cutting and Coagulation Accessories, Electrosurgical Wands Classification: Class II per 21 CFR 878.4400
Predicate Device
MIT's reprocessed electrosurgical cutting and coagulation accessories are substantially equivalent to: Mitek (K974022) or Arthrocare Wands (K962321)
Description of Device
The cutting and coagulation system consists of a system controller that is connected to a power source. Two cables extend from the system controller, one to a foot-pedal to allow the operator to control the device; the other cable leads to the wand portion, which functions in the surgical site. The wand is the accessory for which MIT has developed the reprocessing technology.
Intended Use
The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders. They are supplied sterile.
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Medical Instruments Technology, Inc's. Reprocessed Electrosurgical Wand Premarket Notification
Technological Characteristics
MIT's reprocessed electrosurgical devices have the same technological characteristics as the predicate devices. MIT does not change any of the design characteristics or materials during reprocessing. The only material change, that MIT does make, it that of the sheathing. The sheathing is replaced, because the original sheathing would be damaged in the reprocessing procedures. The replacement sheathing is substantially equivalent to the original sheathing, and actually acts as a better electrical insulator as shown in the dielectric test.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Mr. John P. Batcabe Development Manager Medical Instruments Technology, Inc. 385 North 3050 East Saint George, Utah 84790
Re: K012640
Trade/Device Name: Reprocessed Electrosurgical Wand Regulation Number: 888.1100, 878.4400 Regulation Name: Arthroscope Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: HRX, GEI Dated: December 4, 2001 Received: December 11, 2001
Dear Mr. Haueter:
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 - Mr. John P. Batcabe
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 premated predicated. " 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,
-Mark N. Milhux
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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012640
Medical Instruments Technology, Inc's. Reprocessed Electrosurgical Wand Premarket Notification
Section 3: Indications for Use
Intended Use:
MIT 's unique reprocessing of the wands does not change their intended use. The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders.
Mark N Millman
(Division Sign-Off) Division of General, Restorative and Neurological Devices KO126.40
510(k) Number_