PERSONNA PLUS SAFETY SCALPEL SYSTEM

K032242 · Omi Manufacturing Pty., Ltd. · GES · Sep 23, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032242
• Device Name: PERSONNA PLUS SAFETY SCALPEL SYSTEM
• Applicant: Omi Manufacturing Pty., Ltd.
• Product Code: GES · General, Plastic Surgery
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.

Device Story

PersonnaPlus Safety Scalpel System is a manual surgical instrument featuring a retractable plastic shroud to protect against sharps injuries. Available as a totally disposable unit with a plastic handle or a 'reposable' unit with a stainless steel handle and replaceable blade. Used in surgical, pathology, and minor medical settings by clinicians. The device functions as a standard scalpel with an integrated safety mechanism to shield the blade during loading, passing, and disposal. The safety feature is designed to reduce the risk of accidental injury to healthcare personnel. Substantial equivalence is supported by a simulated user study conducted per FDA guidance for sharps injury prevention features.

Clinical Evidence

No clinical data. Evidence consists of a simulated user study conducted in accordance with the FDA guidance document 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features'.

Technological Characteristics

Manual surgical scalpel with retractable plastic shroud. Materials: stainless steel blades, plastic or stainless steel handles. Supplied sterile. Conforms to applicable ISO standards. No electronic components or software.

Indications for Use

Indicated for use as a cutting device during surgical, pathology, and minor medical procedures for patients requiring surgical intervention.

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

• Los Alamos Retractable Knife (K923170)
• Personna Safety Scalpel (K924503)

Submission Summary (Full Text)

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K032242

## EXHIBIT 2 OMI Manufacturing Pty Ltd Unit 1, 12 Booran Drive Slacks Creek Queensland 4127 Australia Phone : + 61- 7 3209 3099 Fax: + 61- 7 3209 4765 Contact: Mr. Bruce L. Kiehne, Director/Secretary 510(k) Summary

- 1. Identification of the Device: Proprietary-Trade Name: PersonnaPlus Safety Scalpel System also known as OMI Safe Scalpel Classification Name: Blade: GES, Handle: GDZ Common/Usual Name: Scalpel blade, scalpel handle This device is Class I but with sharps injury protection feature.
- 2. Equivalent legally marketed device: K923170 Los Alamos Retractable Knife and Personna Safety Scalpel" K924503
- 3. Indications for Use (intended use) The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.,
- 4. Description of the Device: The device is a combination scalpel blade and handle incorporating a sharps injury protection feature. There are two product options -(1) a totally disposable unit and (2) a metal handle with disposable blade and guard - our "reposable" product. The totally disposable unit uses a plastic handle while the reposable product has a stainless steel handle.

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| Device<br>Characteristics | K923170 Los Alamos<br>Retractable Knife | PersonnaPlus Medical Safety Scalpel<br>and Blades |
|---------------------------|-----------------------------------------|--------------------------------------------------------------------|
| Indications for use | General surgical use | SAME |
| Safety feature | Retractable blade | Blade guard retracts |
| Single use or reusable | Single use only, disposable. | Reusable with change of blade and<br>re-sterilization of handle |
| Blade size(s) | 10, 11, 15 | Handle sizes 3, 4<br>Blade sizes: 10,11,15,15C, 20, 21, 22, 23, 24 |
| Blade material | Stainless steel | SAME |
| Handle material | Plastic | Plastic or Stainless steel |
| Supplied | Sterile | SAME |

- 5. Safety and Effectiveness, comparison to predicate device:
- 6. In all respects, the PersonnaPlus Safety Scalpel System also known as OMI Safe Scalpel are substantially equivalent to one or more scalpels currently marketed in the USA. The scalpels are constructed of identical materials and conform to applicable ISO standards. An added safety feature of a retractable plastic shroud around the blade enhances safety. A successful simulated user study was conducted according to FDA guidance document Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA Document Issued on: December 31, 2002

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a human figure, with three wavy lines representing the head, body, and legs.

Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Omi Manufacturing Pty, Limited C/O Mr. George Kreimer Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K032242

Trade/Device Name: Personna Plus Safety Scalpel System Regulation Number: 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: I Product Code: GES, GDZ Dated: September 4, 2003 Received: September 5, 2003

Dear Mr. Kreimer:

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.

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Page 2 -Mr. Kreimer

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.

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/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## k) Indications for Use

510(k) Number

Device Name: PersonnaPlus Safety Scalpel System also known as OMI Safe Scalpel..

Indications for Use: The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use (Per 21 CFR 801.109)

Patricio Cussenite

OR

10(k) Number: K032242