HARMONY PORT SYSTEM, MODEL 1907 SERIES

K050706 · Spinal Concepts, Inc. · GZT · Apr 15, 2005 · Neurology

Device Facts

• Record ID: K050706
• Device Name: HARMONY PORT SYSTEM, MODEL 1907 SERIES
• Applicant: Spinal Concepts, Inc.
• Product Code: GZT · Neurology
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.

Device Story

Harmony Port System provides surgical exposure during minimally invasive procedures; includes Harmony Port and accessory instruments for fixation. Device functions as self-retaining retractor; holds wound edges open via self-locking mechanism. Used in clinical settings (OR) by surgeons. Benefits include maintained surgical site visualization and access during procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Self-retaining retractor system; includes port and accessory instruments for rigid fixation. Materials and design are similar to predicate device. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients undergoing general or neurosurgical procedures requiring wound retraction and surgical exposure.

Regulatory Classification

Identification

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

Predicate Devices

• The Bright Medical Dilation Retractor System (K992898)

Submission Summary (Full Text)

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K050706

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## APR 1 5 2005

## 510(k) NOTIFICATION SUMMARY

## THE HARMONY™ PORT SYSTEM

| SUBMITTER: | Spinal Concepts, Inc. |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION<br>NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch<br>Specialist, Regulatory Affairs<br>Telephone:<br>512.533.1840<br>Fax:<br>512.918.2784 |
| DATE: | March 16, 2005 |
| TRADE NAME: | The Harmony™ Port System |
| COMMON NAME: | Surgical Retractor |
| CLASSIFICATION NAME: | Self-Retaining Retractor for Neurosurgery |
| CLASSIFICATION REFERENCE: | 21 CFR § 882.4800 |
| PREDICATE DEVICE: | The Bright Medical Dilation Retractor System<br>manufactured by Bright Medical Instruments,<br>K992898, cleared October 21, 1999. |
| DEVICE DESCRIPTION: | The Harmony Port System includes the Harmony<br>Port, which provides surgical exposure during<br>minimally invasive procedures, along with<br>accessory instruments designed to facilitate the use<br>of the Port and rigidly fix the system during use. |
| INDICATIONS: | To provide a self-locking mechanism to hold the<br>edges of a wound open and allow for surgical<br>exposure during general use and neurosurgical<br>procedures. |
| COMPARISON TO PREDICATE DEVICE: | The Harmony Port System has the same intended<br>use, is manufactured from similar materials using<br>similar processes, and is similar in design when<br>compared to the predicate device. |

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K050706

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PERFORMANCE DATA:

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The results of non-clinical testing and evaluation demonstrate that the device is safe and effective.

.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Noah Bartsch Specialist, Regulatory Affairs Spinal Concepts, Inc. 5301 Riata Park Court, Building F Austin, Texas 78727

Re: K050706

Trade/Device Name: Harmony™ Port System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: March 16, 2005 Received: March 18, 2005

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuate for use stated in the encrosule) to regars actment date of the Medical Device Amendments, or to commence proof to May 20, 1978, the eccordance with the provisions of the Federal Food, DNAA devices that have been recalismod in aber approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appt to the general controls provisions of the Act. The You may, incretore, market the do rec, solo, solo, so annual registration, listing of general controls provisions of the free measure reading, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is eassified (bee are ve) 2008 - 2) 2008 - 1000 - 1000 - 1000 - 100 - 100 - 100 il may be subject to such additional Segulations, Title 21, Parts 800 to 898. In addition, FDA Call be found in the Code of Feasts. East of the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination doss not mean Please be advised that IDA's issualled of a national with other requirements of the Act
that FDA has made a determination that your device complies with other made that FDA has made a decemmation in a your in the Federal agencies. You must or any receral statutes and regulations adminders, but not limited to: registration and listing (21 comply with an the Act 3 requirements) ments of the practice requirements as school in the Alastraliants as set CTK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 CFR 1800 (1950 lorin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Noah Bartsch

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makeemig your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivals and thus, nor premarket noutication. The PDA miding of backantal of an 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
s the results of the same of a comments of any and the reculation entitled If you desire specific advice for your act [phone] . Also, please note the regulation entitled, contact the Office of Complance at (210) 276 of CFR Part 807.97). You may obtain "Misbranding by relevence to premanet noutheansment on the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204) or and Manufacturers, International and Consumer Fibersanter at Access of Act Carling Stry/Support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050706

## Indications for Use

510(k) Number (if known):

Device Name:

Harmony™ Port System

Indications for Use:

To provide a self-locking mechanism to hold the edges of a wound open and allow for To provide a sen-locking meethallion to neeurosurgical procedures.

Prescription Use _X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this linc – Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. E. Turner

30 Edive

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