REPROCESSED ENT SHAVERS

K081814 · Sterilmed, Inc. · ERL · Dec 17, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K081814
• Device Name: REPROCESSED ENT SHAVERS
• Applicant: Sterilmed, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries, and otoneurologic procedures.

Device Story

Reprocessed ENT shavers are powered dissectors used for bone and tissue removal during ENT, head and neck, and otoneurologic surgeries. The device is inserted into a reusable hand piece (not included). Operation involves mechanical cutting/shaving of tissue. Used in clinical settings by surgeons. Reprocessing restores the device to original functional specifications. Benefits include providing a cost-effective, sterile, and functional surgical instrument for tissue debridement and bone removal.

Clinical Evidence

Bench testing only. Functional testing and process validation were performed to verify cleaning, sterilization, and packaging integrity. Visual and functional testing were conducted on all products produced to ensure performance equivalence.

Technological Characteristics

Powered surgical dissector (shaver) for bone and tissue removal. Materials and construction are identical to the original manufacturer's specifications. Device is intended for use with a reusable hand piece. Sterilization is performed as part of the reprocessing cycle.

Indications for Use

Indicated for patients undergoing ENT, head and neck, and otoneurologic surgeries, including sinus applications (polypectomy, ethmoidectomy/sphenoethmoidectomy, septoplasty, antrostomy, endoscopic DCR, frontal sinus trephination/irrigation/drill out, septal spur removal, trans-sphenoidal procedures), head and neck procedures (rhinoplasty, lipodebridement, soft tissue shaving, acoustic neuroma removal), nasopharyngeal and laryngeal procedures (tonsillectomy, tracheal procedures, adenoidectomy, laryngeal lesion de-bulking, laryngeal polypectomy), and otology procedures (mastoidotomy, mastoidectomy).

Regulatory Classification

Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Predicate Devices

• Gyrus Diego
• Medtronic Xomed XPS

Submission Summary (Full Text)

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K081814

Image /page/0/Picture/1 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."

510(K) PREMARKET NOTIFICATION SUBMISSION JUNE 25, 2008 FOR REPROCESSED ENT SHAVERS

#### SUMMARY AND CERTIFICATION II.

DEC 1 7 2008

#### 510(k) Summary A.

| Submitter: | SterilMed, Inc. |
|------------------------|------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joshua Clarin<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 612-644-8402<br>Fax: [phone] |
| Date Prepared: | June 25, 2008 |
| Trade Name: | Reprocessed ENT Shavers |
| Classification Name: | Ear, Nose and Throat Electrical or Pneumatic Surgical Drill |
| Classification Number: | Class II, 21 CFR 874.4250 |
| Product Code: | ERL |

| Predicate<br>Devices: | The reprocessed ENT shavers are substantially equivalent to Gyrus Diego® and Medtronic<br>Xomed XPS® shavers. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed's reprocessed ENT shavers are powered dissectors inserted into a reusable hand<br>piece and designed to be used in the removal of bone and tissue in various ENT, head and neck<br>surgeries, and otoneurologic procedures. These devices were originally manufactured by Gyrus<br>and Medtronic. |
| | Note: Only the shaver is the subject of this submission, the reusable hand piece and any other<br>related equipment are not included in the scope of this submission. |
| Intended Use: | The reprocessed ENT shavers are intended to be used with a reusable hand piece and are<br>designed for use in various ENT, head and neck surgeries, and otoneurologic procedures. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed ENT shavers were tested to demonstrate appropriate<br>functional characteristics. Process validation testing was performed to validate the cleaning and<br>sterilization procedures as well as device packaging. In addition, the manufacturing process<br>includes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed ENT shavers are substantially equivalent to Gyrus Diego® and Medtronic<br>Xomed XPS® blades. |
| | This conclusion is based upon the devices' similarities in functional design (principle of<br>operation), materials, indications for use and methods of construction. |

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Image /page/1/Picture/0 description: The image shows the logo for SterilMed INC. The logo is in bold, black font. Underneath the company name, it says "Medical Device Reprocessing" and "Small Equipment & Instrument Repair".

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## 510(K) PREMARKET NOTIFICATION SUBMISSION JUNE 25, 2008 FOR REPROCESSED ENT SHAVERS

K081814

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#### B. Premarket Notification Statement

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In lieu of a Premarket Notification Statement, a 510(k) Summary has been provided. Refer to Section II.A for 510(k) summary and certification.

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CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed. Inc. c/o Dennis Toussaint Director Regulatory Affairs 11400 73rd Avenue, N. Suite 100 Maple Grove, MN 55369

# DEC 1 7 2008

K081814 Re: Trade/Device Name: Reprocessed ENT Shavers Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: December 12, 2008 Received: December 15, 2008

Dear Mr. Toussaint:

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 (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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egolints, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K081814

# Indications for Use

510(k) Number (if known):_K081814

Device Name: Reprocessed ENT Shavers

### Indications for Use:

Indications tor Use:
The reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries and otoneurologic procedures.

Sinus Applications:

- Polypectomy .
- Ethmoidectory/Sphenoethmoidectomy
- Septoplasty
- Antrostomy
- Endoscopic DCR .
- Frontal Sinus Trephination and Irrigation
- Frontal Sinus Drill Out
- Septal Spur Removal
- Trans-Sphenoidal Procedures

## Head and Neck Procedures

- Rhinoplasty .
- Lipodebridement in the Maxillary and Mandibular Region .
- Soft Tissue Shaving
- Acoustic Neuroma Removal

Nasopharyngeal and Laryngeal Procedures

- Tonsillectomy .
- Tracheal Procedures .
- Adenoidectomy
- Laryngeal Lesion De-Bulking
- Laryngeal Polypectomy .

# Otology Procedures

- Mastoidotomy .
- Mastoidectomy

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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sir Nadler

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number k081814

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# K081814

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Carlos Concession

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| Manufacturer | Model # |
|-----------------|-------------|
| Gyrus | 7013-8100 |
| | 7013-8000 |
| | 7013-8035 |
| | 7013-8001 |
| | 7013-8002 |
| | 7013-8003 |
| Medtronic Xomed | 18-84004HR |
| | 18-84004 |
| | 18-83504HR |
| | 18-83504 |
| | 18-82904HRE |
| | 18-82904 |
| | 18-84002HRE |
| | 18-84002 |
| | 18-83502HRE |
| | 18-83502 |
| | 18-82902HRE |
| | 18-82902 |
| | 18-84005HRE |
| | 18-84005 |
| | 18-82905HRE |
| | 18-82905 |
| | 18-82040HR |
| | 18-82040 |
| 18-82940HR | |
| 18-82940 | |

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List of Devices included in this Premarket Notification Submission - 510(k) K081814

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