(74 days)
The VertiFlex® Direct Decompression System is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
The VertiFlex® Direct Decompression System consists of a group of instruments intended to assist in the performance of lumbar decompression through a minimallyinvasive approach. The instruments include both reusable, and single-use disposable devices. In combination, these instruments include dilators and a cannula through which the user may gain access to the site of decompression, and several specialized instruments with which both bony and soft tissue may be removed to decompress the neural elements. The single-use disposable devices will be provided sterile, and the reusable devices will be provided non-sterile for sterilization by the user before use.
The provided text is a 510(k) summary for the VertiFlex® Direct Decompression System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets these criteria in the context of clinical performance or diagnostic accuracy.
The summary explicitly states:
- "No clinical testing was conducted to support this submission." (Section 5.8)
- Non-clinical tests included "simulated decompression surgery in human cadavers, conducted to validate the performance of the subject System." (Section 5.7)
Therefore, based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or expert involvement as typically requested for studies evaluating diagnostic or clinical effectiveness. The submission focuses on substantial equivalence based on design characteristics, materials, and indications to existing predicate devices.
Here's what can be extracted from the document regarding testing and its purpose:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria related to clinical outcomes or diagnostic performance are presented.
- No reported device performance metrics (e.g., sensitivity, specificity, accuracy, clinical success rates) are provided. The submission focuses on demonstrating substantial equivalence to predicate devices through design and intended use comparisons.
2. Sample sized used for the test set and the data provenance
- The "test set" described is simulated decompression surgery in human cadavers. The sample size for this test set is not specified.
- The data provenance is non-clinical (cadaveric testing). The country of origin is not specified, and it is inherently prospective in that novel testing was conducted with the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the cadaveric testing was for "performance validation" of the system, not for establishing clinical ground truth for a diagnostic or treatment outcome.
4. Adjudication method for the test set
- This information is not provided.
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 MRMC comparative effectiveness study was done. This device is a surgical instrument, not an imaging AI or diagnostic tool where such a study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical instrument system, not an algorithm.
7. The type of ground truth used
- For the non-clinical cadaveric testing, the "ground truth" would likely be the ability of the instruments to perform the intended surgical actions (e.g., removal of bony and soft tissue to decompress neural elements) without breakage or functional failure, as observed by the operating surgeon(s) during the simulation. This is performance validation, not clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided submission focuses on demonstrating substantial equivalence to legally marketed predicate devices for a surgical instrument system, rather than proving clinical effectiveness or diagnostic performance through specific acceptance criteria and clinical trials.
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August 30, 2012
5.0
In accordance with Title 21 Code of Federal Regulations (21 CFR), Part 807, and in particular. §807.92, the following 510(k) summary is provided for the VertiFlex® Direct Decompression System:
5.1 Submitted By:
VertiFlex®. Incorporated 1351 Calle Avanzado San Clemente, California 92673
GIOK
SUMMARY
Contact: Steve Reitzler, Vice President, Clinical & Regulatory Affairs
Date Prepared: August 30, 2012
5.2 Device Name
Trade or Proprietary Name: Direct Decompression System Common or Usual Name:
Common or Usual Name.
Arthroscope Accessories
Classification Name: Arthroscope
5.3 Predicate Devices
The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate device:
Vertos Medical mild® Device Kit (Vertos Medical, Inc .; K093062)
We also note that the functions of some System components do not differ from those of a manual rongeur as described in §882.4840 (e.g., Baxano, Inc. iO-Flex® System; K062711), or from various orthopedic manual surgical instruments as described in §888.4540 (Class I; 510[K] exempt)
5.4 Device Description
The VertiFlex® Direct Decompression System consists of a group of instruments intended to assist in the performance of lumbar decompression through a minimallyinvasive approach. The instruments include both reusable, and single-use disposable devices. In combination, these instruments include dilators and a cannula through which the user may gain access to the site of decompression, and several specialized instruments with which both bony and soft tissue may be removed to decompress the neural elements. The single-use disposable devices will be provided sterile, and the reusable devices will be provided non-sterile for sterilization by the user before use.
ર્સ્ટ Intended Use
The subject device is indicated for use as follows:
The VertiFlex® Direct Decompression System is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
NOV 1 3 2012
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August 30, 2012
Comparison to Predicate Devices 5.6
Comparisons of design characteristics and features have established that the subject VertiFlex® Direct Decompression System is substantially equivalent in design, materials, indications, and other features, to other predicate decompression kits or devices commercially available in the U.S.
5.7 Summary of Non-Clinical Tests
Non-clinical tests included the performance of simulated decompression surgery in human cadavers, conducted to validate the performance of the subject System.
Summary of Clinical Tests ર જ
No clinical testing was conducted to support this submission.
5.9 Conclusions
The results of testing and comparison demonstrated the substantial equivalence of the subject Direct Decompression System to the identified predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 13, 2012
VertiFlex®, Incorporated % Mr. Steve Reitzler Vice President. Clinical and Regulatory Affairs 1351 Calle Avanzado San Clemente, California 92673
Re: K122662
Trade/Device Name: VertiFlex® Direct Decompression System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 30; 2012 Received: August 31, 2012
Dear Mr. Reitzler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. Steve Reitzler
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
62 510(k) Number (if known):
VertiFlex® Direct Decompression System Device Name: ______
Indications for Use:
The VertiFlex® Direct Decompression System is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for MKM | |
|---|---|
| -- | --------- |
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K122662 |
|---|---|
| --------------- | --------- |
§ 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.