QUADRANT RETRACTOR SYSTEM

K043602 · Medtronic Sofamor Danek · GAD · Feb 23, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043602
• Device Name: QUADRANT RETRACTOR SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: GAD · General, Plastic Surgery
• Decision Date: Feb 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

The MAST QUADRANT™ Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variety of spinal fixation procedures utilizing a minimally invasive approach. The MAST QUADRANT™ Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANT™ Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants.

Device Story

MAST QUADRANT™ Retractor System is a tubular-based surgical instrument set for minimally invasive spinal access. System components include dilators, articulating/distracting retractor blades, light sources, and pedicle access needles. Operated by surgeons in an OR setting to dilate overlying tissues and maintain surgical field access. Compatible with external visualization aids like microscopes, cameras, and light sources. By providing a stable, adjustable portal to the spine, the system facilitates procedures such as decompression, discectomy, and fusion. Benefits include improved visualization and access to the surgical site through a minimally invasive approach, potentially reducing tissue trauma compared to traditional open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tubular-based manual surgical retractor system. Components include dilators, articulating blades, light sources, and pedicle access needles. Designed for use with external visualization aids (microscopes, cameras). Non-powered, manual instrumentation.

Indications for Use

Indicated for visualization of the surgical field in any body area during surgery. Specifically for cervical, thoracic, or lumbar spine procedures (anterior or posterior approach) including herniated disc repair, nerve root decompression, nucleus material removal, spinal fusion, or spinal implant insertion.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• METRx, MED, Inclusive, and/or INCL Microscopes (K002931)
• EQUESTRA™ Fluid Delivery System (K040483)

Submission Summary (Full Text)

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## MAST QUADRANT™ Retractor System 510(k) Summary February 2005 K043602

- Medtronic Sofamor Danek Company: I. 1800 Pyramid Place Memphis, TN 38132 [phone]
Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs

#### Proprietary Trade Name: MAST QUADRANT™ Retractor System II.

- Classification Name: Retractors, Manual Surgical Instrument III.
- Regulation Number: Class I Exempt as described in 21 CFR 878.4800 and 888.1100. IV. Product Code GAD, NBH

#### V. Product Description

The MAST QUADRANT™ Retractor System is a tubular-based retraction system, designed to provide surgeons with the freedom to retract tissue through any combination of distracting or articulating the blades. The MAST QUADRANT™ System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to maintain the access. The system can be used in conjunction with microscopes, light sources, cameras, or other visualization aids.

#### VII Indications

The MAST QUADRANT™ Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variety of spinal fixation procedures utilizing a minimally invasive approach.

The MAST QUADRANT™ Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANT™ Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants.

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K043602

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#### Substantial Equivalence VIII

Documentation was provided which demonstrated the subject MAST QUADRANT™ Retractors to be substantially equivalent to the METRx, MED, Inclusive, and/or INCL Microscopes described in Medtronic Sofamor Danek 510(k) No. K002931 (SE 11/24/00), while the pedicle access needles included in the system are identical to those cleared in the EQUESTRA™ Fluid Delivery System (K040483, SE 07/23/04).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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FEB 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K043602

Trade/Device Name: MAST QUADRANTTM Retractor System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: II Product Code: FSZ, GAD, NBH Dated: February 2, 2005 Received: February 4, 2005

Dear Dr. Treharne:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Dr. Treharne

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Miriam C Provost

Celia M. Witten, PhD., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KOA 3607

Page 1 of 1 December 2004

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

MAST QUADRANTTM Retractor System _____________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

### Indications for Use:

The MAST OUADRANT™ Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variety of spinal fixation procedures utilizing a minimally invasive approach.

The MAST QUADRANT™ Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANT™ Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

K043602 510(k) Number ________________________________________________________________________________________________________________________________________________________________

0000000

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