← Product Code [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX) · K122662

# VERTIFLEX DIRECT DECOMPRESSION SYSTEM (K122662)

_Vertiflex, Inc. · HRX · Nov 13, 2012 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K122662

## Device Facts

- **Applicant:** Vertiflex, Inc.
- **Product Code:** [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX.md)
- **Decision Date:** Nov 13, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.1100
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## 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.

## Device Story

VertiFlex Direct Decompression System comprises specialized surgical instruments for minimally invasive lumbar decompression. System includes dilators, cannula for site access, and specialized instruments for bony and soft tissue removal. Used by surgeons in clinical settings to decompress neural elements. Single-use components provided sterile; reusable components provided non-sterile for user sterilization. Device facilitates tissue removal to treat spinal conditions; benefits patient through minimally invasive approach.

## Clinical Evidence

No clinical testing was conducted. Evidence consists of non-clinical bench testing, specifically simulated decompression surgery performed in human cadavers to validate system performance.

## Technological Characteristics

Set of manual surgical instruments including dilators, cannulas, and tissue removal tools. Materials include both reusable and single-use disposable components. Reusable devices require user-performed sterilization. No electronic, software, or energy-based components.

## Regulatory 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.

## Predicate Devices

- Vertos Medical mild® Device Kit ([K093062](/device/K093062.md))

## Reference Devices

- Baxano, Inc. iO-Flex® System ([K062711](/device/K062711.md))

## Submission Summary (Full Text)

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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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K122662

Page 2 of 2

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 |
|---------------|---------|
|---------------|---------|

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K122662](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K122662)

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