(74 days)
No
The summary describes a set of surgical instruments for lumbar decompression and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a set of specialized surgical instruments used to perform lumbar decompressive procedures, not a therapeutic device itself. Its purpose is to assist in surgical procedures.
No
The device is described as a set of surgical instruments used for performing lumbar decompressive procedures, not for diagnosing conditions.
No
The device description explicitly states it consists of "a group of instruments" including "reusable, and single-use disposable devices" such as "dilators and a cannula" and "specialized instruments," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the VertiFlex® Direct Decompression System is a set of surgical instruments used to perform lumbar decompressive procedures. This is a surgical intervention performed directly on the patient's body.
- Device Description: The description details surgical instruments like dilators, cannulas, and instruments for removing tissue. These are tools for performing surgery, not for analyzing samples from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided describes a surgical device used for treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar
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)
Non-clinical tests included the performance of simulated decompression surgery in human cadavers, conducted to validate the performance of the subject System.
No clinical testing was conducted to support this submission.
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.
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.
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.
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Page 1 of 2
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
3
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
4
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 |
|---|---|
| --------------- | --------- |