MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION

K003740 · Aesculap, Inc. · HRX · Apr 27, 2001 · Orthopedic

Device Facts

• Record ID: K003740
• Device Name: MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
• Applicant: Aesculap, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for use as a specialized manual surgical instrument. It is reusable and is intended to provide access to the anterior thoracic and lumbar spinal column during minimally invasive and endoscopic surgical procedures. Provides a self-locking type surgical retraction system with inflatable tissue protectors.

Device Story

The miaspas® miniTTA is a reusable, manual, self-retaining spinal retractor system used by surgeons to provide access to the anterior thoracic and lumbar spine during minimally invasive and endoscopic procedures. The system consists of various retractor blades (lung, rib, diaphragm) and a handle; it features inflatable tissue protectors to assist in retraction. The device is operated by a physician in a healthcare facility. It functions by mechanically holding the edges of a surgical wound open, providing a clear view and instrument access to the vertebral space. The system is designed to be sterilized via steam autoclave.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence is established through comparison of design, materials, and intended use to legally marketed predicate devices.

Technological Characteristics

Manual, self-retaining retractor system. Materials: Titanium alloy. Components: Tray, retractor, counter retractor, lung retractor, rib retractor, diaphragm retractor, lung retractor with inflatable cuff, handle, forceps. Sterilization: Steam autoclave. Form factor: Specialized surgical instrumentation for transthoracic/lumbar access.

Indications for Use

Indicated for patients undergoing minimally invasive or endoscopic surgical procedures of the anterior thoracic and lumbar spinal column requiring tissue retraction.

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

• Surgical Dynamics Spinal Retractor (K002008)
• Lumbar Nerve Root Shield (K780706)
• Dilation Retractor System (K992898)

Submission Summary (Full Text)

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# APR 2 7 2001

Koo3740

afety and Eff Section 510(k) PRICE 2001 narket Nothcation.

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

> miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation Trade Name:

Spinal retractor Common Name(s):

Classification Name(s):

Spinal retractor, self-retaining retractor for neurosurgery

#### Establishment Name & Registration Number:

Name: Aesculap® Inc. 2916714 Number:

#### Classification(s):

#### & 882.4800 Self retaining retractor for neurosurgery.

(a) Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

(b) Classification. Class II (performance standards).

Device Class: Classification Panel: Product Code(s):

Class II for the requested indications Orthopaedic and Neurosurgery Devices Panel HRX, GZT

#### Applicant Name & Address:

Aesculap® Inc. 944 Marcon Blvd. Allentown, PA 18109 650.876.7000 voice - 650.876.0266 fax

#### Company Contact:

Ms. Joyce Thomas Aesculan® Inc. 944 Marcon Blvd. Allentown, PA 18109 650.876.7000 voice - 650.876.0266 fax

#### Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C - 100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

#### Labeling:

The miaspass miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation discussed in this summary is made in Germany by AESCULAR® AG & CO. KG. The system will be marketed exclusively to healthcare facilities and physicians.

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Koo 3740

201=2

Surgical Technique. The surgical approach used with the miaspas® min1TTA Anterior Micro Surgical Transthoracic Approach Instrumentation is similar to other spirial retractor systems and instruments.

Warning: Federal (United States) Law restricts this device to sale by or on the order of a physician only.

### Preaments Device (legally marketed comparison device):

AESCULAP® Inc. believes that the milaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is substantially equivalent to the following spinal retractors marketed by Surgical Dynamics, Inc. and Brigfht Medical Instruments.

- Surgical Dymanics Spinal Retractor K002008, Surgical Dynamics, Inc. .
- Hever- Shulte Corporation, K780706, Lumbar Nerve Root Shield .
- Dilation Retractor System K992898, Bright Medical Instruments, Inc. .

To facilitate comparison of the maspas® miniTTA Anterior Micro Surgical Transthoratic Approach Instrumentation to the systems identified above, a basic feature companson table is located at the end of the document.

### Summary Basis for Equivalence and Comparison Table:

- The devices have the same intended use and/or indications for use. ●
- The devices are made of comparable instrument grade materials. .
- . The devices have similar function, surgical approach, instruments and features.

The use of ISO & QSR based process controls and the similarities of the references companson devices establish that the milaspass miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is substantially equivalent to available legally marketed spinal retractors. It is believed that the anticipated clinical performance of the miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is equivalent to the referenced systems.

| FEATURE | miaspas® miniTTA Anterior Micro Surgical<br>Transthoracic Approach Instrumentation | Surgical Dynamics<br>retractor | Bright Medical Dilation retractor<br>System | SE? |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indications<br>for Use: | The device is intended for use as a<br>specialized manual surgical instrument.<br>It is reusable and is intended to provide<br>access to the anterior thoracic and<br>lumbar spinal column during minimally<br>invasive and endoscopic surgical<br>procedures. Provides a self-locking type<br>surgical retraction system with inflatable<br>tissue protectors. | Hollow rigid instrument for<br>use in spine surgery for<br>viewing and instrument<br>access to the vertebral<br>space. Retracts tissue<br>during open and endoscopic<br>procedures. | Dilators, tubular retractors &<br>guide wires used to provide<br>minimally invasive surgical<br>access to the spine.<br>Positioned down to the<br>surface of the spine using<br>self-locking flexible arm. | YES |
| Components: | Tray, retractor, counter retractor, lung<br>retractor, rib retractor Sm. & Lg.,<br>diaphragm retractor Sm., Med., Lg.,<br>Lung retractor w/ inflatable cuff Sm.,<br>Med., Lg., handle for retractor blades,<br>forceps for retractor blade & drape. | 3 sizes | 5 dilators, 3 tubular<br>retractors, 1 guidewire,<br>flexible attachment arm. | YES |
| Sterilization: | Steam autoclave | Same | Same | YES |
| Materials: | Titanium alloy | Stainless steel | Stainless Steel | YES |
| | | | | YES |
| Manufacturer | Aesculap | Surgical Dynamics, Inc. | Bright Medical, Inc. | YES |
| Surgical<br>Approach: | Transthroacic | Lateral/transthoracic | Lateral/transthoracic | YES |
| Product<br>Code: | GZT. HRX | GZT, HRX | GZT | YES |
| K - Number: | Pending | K002008 | K992898 | YES |

#### Summary Comparison Table:

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APR 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory lane Suite C-100 Pleasant Hill, California 94523

Re: K003740

Trade/Device Name: miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation Regulation Number: 888.1100, 882.4800 Regulatory Class: II Product Code: HRX, GZT Dated: February 7, 2001 Received: March 12, 2001

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David W. Schlerf

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Milkan

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

Enclosure

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Page 1

**510(k) Number**: K003740

IIIIIaSDas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation Device Name(s):

## Indications for Use:

# Self-retaining retractor for neurosurgery & Spinal retractor

The device is intended for use as a specialized manual surgical instrument. It is reusable and is intended to provide access to the anterior thoracic and lumbar spinal column during minimally invasive and endoscopic surgical procedures. Provides a self-locking type surgical retraction system with inflatable tissue protectors.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Millican

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

510(k) Number K003740
Over-The-Counter Use

(Optional format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

OR