(90 days)
The Mitek Vapr Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery could include, for example, the following: Knee Meniscectomy Lateral Release Chondroplasty Synovectorny ACL Debridement Plica Removal Meniscal Cystectomy Ankle Fracture Debridement Excision of Scar Tissue Synovectomy Chondroplasty Wrist Synovectomy Carilage Drbridement Fracture Debridement Shoulder Labral Tear Resection Synovectomy Excision of Scar Tissue Acromioplasty Bursectomy Subacromial Decompresion Chondropiasy Elbow Synovectomy Tendom Debridement Chondroplasty
The Mitek Vapr™ system is comprised of four components: the electrosurgical generator, a footswitch, a handpiece with a cable to connect to the generator and five types of electrode tip configurations used in the arthroscopic procedure.
The Mitek Vapr System is designed for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissues.
Here's an analysis of the provided information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended for general surgical and arthroscopic applications. | Preclinical animal studies and laboratory evaluations confirmed the device functions as intended. |
| Safety and effectiveness comparable to predicate device. | Preclinical animal testing supported safety and effectiveness comparable to the predicate (Oratec system). |
| Substantial equivalence to predicate device. | Concluded to be substantially equivalent to the Predicate Device (Oratec Interventions™ Model ORA 50 Electrothermal Generator and Accessories). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Preclinical animal studies and laboratory evaluations" and "preclinical animal testing," but doesn't provide specific numbers for the animal studies or laboratory evaluations.
- Data Provenance: The studies were preclinical animal studies and laboratory evaluations. The country of origin is not specified, but the submission is to the U.S. FDA, implying the data would be acceptable under their regulations. The data is prospective in nature, as it was generated specifically to support the device's claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The studies were preclinical animal studies and laboratory evaluations, which typically rely on objective measurements and observations rather than expert consensus on a test set of data in the way human clinical trials might.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. As explained above, the assessment was based on preclinical animal studies and laboratory evaluations of device function and comparison to a predicate, not on a test set requiring expert adjudication in the context of diagnostic performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This document pertains to the 510(k) submission of an electrosurgical device, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI" is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a surgical system, not a standalone algorithm. Its performance is assessed as a physical device.
7. The Type of Ground Truth Used
- For the preclinical animal studies and laboratory evaluations, the ground truth would have been based on direct observation and measurement of the device's effects (e.g., tissue resection, ablation, hemostasis, coagulation) in an in vivo (animal) and in vitro (laboratory) setting. The comparison was also made directly against the predicate device's performance under similar conditions.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical electrosurgical system, not a machine learning or AI algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo for Mitek Products. The word "mitek" is in bold, black letters, with the "k" slightly raised. Below the word "mitek" is the word "PRODUCTS" in smaller, black letters.
JAN 12 1998
ETHICON,INC.
a Johnson&Johnson company
60 GEAUIEN DHIVE - WEUTH OSBER ... FAX (781) 356-4835 • FAX (781) 461-9166
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SUMMARY OF SAFETY AND EFFECTIVENESS
DATE
November 7, 1997
510(k) Summary of
Safety and Effectiveness
Information supporting claims of substantial equivalence a defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule" ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Mitek Vapr™ System DEVICE NAME CLASSIFICATION NAME Arthroscope and Accessories (21CFR 888.1100) TRADE NAME/PROPRIETARY NAME Vapr™
PREDICATE DEVICE NAME
Oratec Interventions™ Model ORA 50 Electrothermal Generator and Accessories.
SUMMARY
Device Indications:
The Mitek Vapr"M Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostastis of blood vessels and in coagulating soft tissues.
Technological Characteristics:
The Mitek Vapr system is technologically the same as the predicate device. Both devices use high frequency electrosurgical current to achieve the intended clinical purpose. The predicate device is mono-polar and the Mitek device is bi-polar. This difference does not raise any new question of safety and effectiveness.
Device Description:
The Mitek Vapr™ system is comprised of four components: the electrosurgical generator, a footswitch, a handpiece with a cable to connect to the generator and five types of electrode tip configurations used in the arthroscopic procedure.
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PERFORMANCE DATA
Preclinical animal studies and laboratory evaluations were conducted to show that the device functions as intended. In preclinical laboratory evaluations, the Oratec system was used for comparison. Clinical data was deemed unnecessary to support the Premarket Notification. Sufficient data has been obtained from preclinical animal testing to assess safety and effectiveness characteristics of the device when compared to the predicate device.
CONCLUSIONS
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act.
CONTACT
Mr. Edward F. Kent Vice President Regulatory Affairs / QA Mitek Products 60 Glacier Drive Westwood, MA 02090
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Mr. Edward F. Kent Vice President, Regulatory Affairs Mitek Products 60 Glacier Drive Westwood, Massachusetts 02090
Re: K974022 Trade Name: VAPR™ Regulatory Class: II Product Code: GEI Dated: October 10, 1997 Received: October 14, 1997
Dear Mr. Kent:
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 requirements , as set forth in the Quality System Regulation (OS) 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
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Page 2 - Mr. Kent
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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
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| Page | |
|---|---|
| Participant Property | |
| 1 | |
| Ol | |
510(k) Number (if known):___
Mitek Vapr System Device Name:
Indications For Use:
The Mitek Vapr Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and
arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues.
(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
| 510(k) Number | K974022 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | ------------------------------------------ |
OR
Over-The-Counter Use ____
(Optional Format 1-2-96)
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Section 2
INDICATIONS FOR USE, CONTRAINDICATIONS
INDICATIONS FOR USE
The Mitek VAPR Generator and Accessories, in combination with Vapt thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery could include, for example, the following:
Knee
Meniscectomy Lateral Release Chondroplasty Synovectorny ACL Debridement Plica Removal Meniscal Cystectomy Ankle Fracture Debridement Excision of Scar Tissue Synovectomy Chondroplasty Wrist Synovectomy Carilage Drbridement Fracture Debridement Shoulder Labral Tear Resection Synovectomy Excision of Scar Tissue Acromioplasty Bursectomy Subacromial Decompresion Chondropiasy Elbow Synovectomy Tendom Debridement Chondroplasty
CONTRAINDICATIONS
The Mitek Vapr system is contraindicated in any non-arthroscopic surgical procedure and in procedures where saline of Ringer's lactate is not used as an irrigant. The System is also not appropriate for patiens for whom an arthroscopic procedure is contraindicated for any reason. Use of the System is also contraindicated in patients with heart pacestakers or other electronic device implants.
Picollo
(Division Sign-Off)
Division of General Restorative Devices K974022
510(k) Number
Prescription Use (Per 21 CFR 801.109)
§ 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.