(29 days)
Not Found
No
The summary describes a surgical system and electrodes for soft tissue procedures, with no mention of AI, ML, image processing, or data-driven algorithms. The submission is a Special 510(k) for a device modification, focusing on design control and validation testing, not AI/ML performance.
Yes
The device is described as being used for "resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues" during arthroscopic surgery, which are therapeutic interventions.
No
The device is intended for surgical procedures (resection, ablation, excision) and coagulation of soft tissues, not for diagnosing conditions.
No
The device description explicitly states the devices are "sterile, disposable electrodes," which are hardware components. The intended use also describes a "System" and "Electrode," further indicating hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as "sterile, disposable electrodes designed for use with the Mitek VAPRTM System." Electrodes used in surgical procedures are not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The Mitek VAPR™ System, when used with a VAPR™ 2.3mm Side Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HRX
Device Description
The devices described in this 510(k) are sterile, disposable electrodes designed for use with the Mitek VAPRTM System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, ankle, elbow and wrist
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)
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing) for the device modification.
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.
K974022 - Mitek VAPR™ T Thermal Electrode, K963783 – Mitek VAPR™ System
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
SEP 24 1999
Mitek Products VAPRTM 2.3mm Side Effect Electrode Special 510(k) Premarket Notification: Device Modification August 25, 1999
Image /page/0/Picture/3 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'k', followed by the numbers '99', then '28', and finally '76'. The characters are written in a cursive style, with varying stroke thicknesses.
510(k) Summary
| Trade Name: | VAPR™ 2.3mm Side Effect Electrode | |
|---|---|---|
| Sponsor: | Mitek Products | |
| 60 Glacier Drive | ||
| Westwood, MA 02090 | ||
| Registration #1221934 | ||
| Contact Person: | Paula E. Bulger | |
| Manager, Regulatory Affairs | ||
| Mitek Products | ||
| 60 Glacier Drive | ||
| Westwood, MA 02090 | ||
| Phone: (781) 251-2746 | ||
| Fax: (781) 461-9166 | ||
| Date: | August 25, 1999 | |
| Device Generic Name: | Electrosurgical electrode | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class II. | ||
| Product Code: | GEI (21 CFR 878.4400) | |
| Predicate Devices: | K974022 - Mitek VAPR™ T Thermal Electrode | |
| K963783 – Mitek VAPR™ System |
Product Description: The devices described in this 510(k) are sterile, disposable electrodes designed for use with the Mitek VAPRTM System.
Indications for Use:
The Mitek VAPRTM System, when used with a VAPR™ 2.3mm Side Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
Safety and Performance:
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing) for the device modification.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VAPT™ 2.3mm Side Effect Electrodes have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
1
Image /page/1/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 representation of three human profiles facing to the right, stacked on top of each other. The profiles are formed by curved lines that create a sense of movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Ms. Paula E. Bulger Regulatory Affairs Manager MITEK Products 60 Glacier Drive Westwood, Massachusetts 02090
Re: K992876
Trade Name: VAPR™ 2.3mm Side Effect Electrode for use with VAPR™ System Regulatory Class: II Product Code: HRX, GEI Dated: August 25, 1999 Received: August 26, 1999
Dear Ms. Bulger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 – Ms. Paula E. Bulger
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Mitek Products VAPR™ 2.3mm Side Effect Electrode Special 510(k) Premarket Notification: Device Modification August 25, 1999
يَا تي
:
。 ・・・
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Page __ 1___ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _VAPR™ 2.3mm Side Effect Electrode
Indications for Use:
The Mitek VAPR™ System, when used with a VAPR™ 2.3mm Side Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
(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 Devices | K992876 |
| 510(k) Number |
| Prescription Use ✓
| (Per 21 CFR 801.109) | OR | Over-the-Counter Use ______ |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ----------------------------- |