TRANSCORP SPINAL ACCESS SYSTEM

K113352 · Transcorp, Inc. · HRX · Apr 16, 2012 · Orthopedic

Device Facts

• Record ID: K113352
• Device Name: TRANSCORP SPINAL ACCESS SYSTEM
• Applicant: Transcorp, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone.

Device Story

The Transcorp Spinal Access System is a set of stainless steel surgical instruments designed for minimally invasive visualization and access to the anterior spine. The system includes orientation guides (5°-15° angulation), fixation pins (12-16mm), drills (2-6mm diameter, 10-18mm depth), cannulated drills, guide pins, a guide pin adapter, a quick disconnect handle, a fixation pin driver, a tamp, and a mallet. Used by surgeons in an operating room setting, the instruments facilitate access to the spine to assist in procedures such as herniated disc repair, biopsy, or bone harvesting. The device provides the physical means for the surgeon to visualize and access the target site, aiding in clinical decision-making and procedural execution during spinal surgery.

Clinical Evidence

No clinical data. Evidence consists of bench testing and cadaver performance testing to demonstrate functional equivalence to the predicate device.

Technological Characteristics

Stainless steel surgical instruments including orientation guides, fixation pins, drills, cannulated drills, guide pins, adapters, handles, tamps, and mallets. Mechanical device; no energy source or software. Sterilization method not specified.

Indications for Use

Indicated for patients requiring minimally invasive visualization and access to the anterior spine for surgical procedures including herniated disc repair, biopsy, or autogenous bone harvesting.

Regulatory Classification

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

• TranS1 Trans-Sacral Spinal Access and Preparation (K032891)

Submission Summary (Full Text)

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## 11/3352

### 510(k) Summary Pursuant to 21 CFR 807.92c

Submitted By:

Andrew Rodenhouse Transcorp, Inc. 1000 100th St. SW Suite F Byron Center, MI 49315 Ph: 616-855-5375 Fax: [phone]

Date:

March 29, 2012

Device Information:

Transcorp Spinal Access System Trade Name:

Common Name: Rigid Endoscope and Instrument Set

21 CFR Section 888.1100, Arthroscope Product Classification: Code: HRX

Substantially Equivalent Device:

TranS1 Trans-Sacral Spinal Access and Preparation K032891: Device

Device Description:

The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components:

- Left and right orientation guides with 5°-15° of angulation
- Fixation pins, 12-16mm
- Drills, 2-6mm Diameter x 10-18mm Depth
- Cannulated Drills, 2-6mm Diameter x 10-18mm Depth
- Guide Pin Adapter

TransCorp Spinal Access System 510(k) Premarket Notification

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- Guide Pins ●
- Quick Disconnect Handle .
- Fixation Pin Driver
- Tamp .
- Mallet .

#### Intended Use:

The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone.

#### Comparison to Predicate:

The Transcorp Spinal Access System and the predicate device include similar stainless steel instruments used in accessing the spine. The Transcorp Spinal Access Systems shares the same technological characteristics including the types of instruments included, the material, and the function as the predicate system.

#### Summary of Non Clinical Testing:

Cadaver performance testing, functional testing, and comparison to the predicate demonstrated that the Transcorp Spinal Access System can be used in accordance with the Indications for Use.

#### Conclusion

Nonclinical tests demonstrate that the Transcorp Spinal Access System is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.

TransCorp Spinal Access System 510(k) Premarket Notification

ನ್ನಾಗಿ

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Transcorp, Inc. % Mr. Andrew Rodenhouse 1000 100th Street SW, Suite F Byron Center, Michigan 49315

Re: K113352

Trade/Device Name: Transcorp Spinal Access System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 30, 2012 Received: March 30, 2012

Dear Mr. Rodenhouse:

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 r reaso be as nove a determination that your device complies with other requirements of the Act that + Drivel statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

APR 1 6 2012

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Page 2 - Mr. Andrew Rodenhouse

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 (OS) 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/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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Mark N. Mullen

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number:

KI13352

Transcorp Spinal Access System Device Name:

Indications for Use:

The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.

X Prescription Use_ (per CFR 801.109)

Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Dyke for mxm
(Division Sign-Off)

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Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113352

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TransCorp Spinal Access System 510(k) Premarket Notification