(25 days)
No
The description focuses on mechanical and electrical functions (cutting, evacuation, electrocauterization, rotating burr, liquid-jet driven motor) and does not mention any AI/ML components or capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used in orthopedic surgical procedures to cut, remove, and shape tissue and bone, which are therapeutic interventions aimed at treating medical conditions.
No
The device description and intended use focus on surgical procedures for cutting, ablating, shaping tissues, and removing or smoothing bone, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly lists hardware components such as a power control unit, pump cartridge, tubing assembly, and handpieces with a rotating burr.
Based on the provided information, the Mitek EXOJET system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a system with a power control unit, pump cartridge, tubing, and handpieces with rotating burrs and drills. These are all components of a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Mitek EXOJET system is a surgical tool used for physical manipulation of tissue and bone during surgery.
N/A
Intended Use / Indications for Use
The Mitek EXOJET* system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.
Product codes
HRX
Device Description
Mitek's EXOJET Tissue Management System consists of reusable power control unit; sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces. It provides the same functions as the predicate device including cutting, evacuation, and electrocauterization. The various handpieces are designed to provide the additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone The handpiece includes a rotating burr, which is driven by a liquid-jet driven motor. It is also available with a variety of burrs and drills.
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
orthopedic surgical procedures
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)
Biocompatibility studies have demonstrated the EXOJET Tissue Safety Management System to be non-toxic, non-irritating, nonsensitizing, and non-cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020688, K002764, K993009, K982266
Reference Device(s)
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
MAY 3 0 2003
SECTION 2 – 510(k) SUMMARY
EXOJET Tissue Management System
| Submitter's Name and
Address: | Mitek Worldwide
a division of ETHICON Inc.
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Sergio J. Gadaleta, Ph.D.
Manager, Regulatory Affairs
Mitek Worldwide
a division of ETHICON Inc.
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone:
781-251-2018
Facsimile:
781-278-9578
e-mail:
sgadalet@ethus.jnj.com |
| Name of Medical Device | Classification Name:
Arthroscope and Accessories
Common/Usual Name:
Arthroscope and Accessories
Proprietary Name:
EXOJET Tissue Management |
| Substantial Equivalence | EXOJET Tissue Management System is substantially equivalent to:
Hydrocision ARTHROJET System with Cautery and TurboBurr
K020688, K002764, K993009, K982266 – Distributed by Mitek
Worldwide a division of Ethicon, Inc., a Johnson & Johnson
Company, 249 Vanderbilt Avenue, Norwood, MA 02062 and
manufactured by Hydrocision Inc., 100 Burtt Road G01, Andover,
MA 01810. |
| Device Classification | Arthroscopes and accessories are classified by FDA as a Class II
Medical Devices under the generic category of Arthroscope
(reference 21 CFR §888.1100), product code HRX. |
1
Mitek's EXOJET Tissue Management System consists of reusable Device Description power control unit; sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces. It provides the same functions as the predicate device including cutting, evacuation, and electrocauterization. The various handpieces are designed to provide the additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone The handpiece includes a rotating burr, which is driven by a liquid-jet driven motor. It is also available with a variety of burrs and drills. The Mitek EXOJE T* system is indicated for orthopedic surgical Indications for Use procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures. Biocompatibility studies have demonstrated the EXOJET Tissue Safety Management System to be non-toxic, non-irritating, nonsensitizing, and non-cytotoxic.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other to form a single shape. The profiles are enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the upper half of the circle.
MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sergio J. Gadaleta, Ph.D. Manager, Regulatory Affairs Mitek Worldwide a division of Ethicon. Inc. 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K031406
Trade/Device Name: EXOJET Tissue Management System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 2, 2003 Received: May 20, 2003
Dear Dr. Gadaleta:
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 - Sergio J. Gadaleta, Ph.D.
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. 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) you may obtain. 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.
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
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EXOJET Tissue Management System
Indications for Use:
The Mitek EXOJET* system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.
for Mark A. Millerson
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number _K031406
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use__