(64 days)
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.
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.
The provided document is a 510(k) summary for the PersonnaPlus Safety Scalpel System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria, a comprehensive study design with sample sizes, expert qualifications, adjudication methods, or MRMC studies.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that 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."
However, it does not provide a specific table of acceptance criteria or the quantitative results (e.g., number of accidental injuries, rate of successful guard deployment) from this simulated user study. The "reported device performance" is broadly stated as enhancing safety and being substantially equivalent.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document (e.g., specific reduction in sharps injuries, deployment success rate of safety feature) | The device's added safety feature (retractable plastic shroud) "enhances safety." A "successful simulated user study was conducted." The device is "substantially equivalent" to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "simulated user study," but does not specify the sample size (e.g., number of users, number of simulated procedures) used for this test.
- Sample Size for Test Set: Not specified.
- Data Provenance: The study was a "simulated user study," implying it was conducted in a controlled environment, likely in Australia (country of origin of OMI Manufacturing Pty Ltd) or the USA (where FDA guidance applies). It would be considered prospective as it's a study specifically conducted for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a simulated user study on a safety scalpel, "ground truth" might refer to expert observation of proper use, safety feature deployment, or assessment of simulated injury events. However, no details are given.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the simulated user study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. MRMC studies are typically for evaluating diagnostic imaging or AI performance where multiple readers interpret cases. This device is a surgical scalpel with a safety feature, so an MRMC study is not directly applicable in its traditional sense. The study conducted was a "simulated user study" focusing on sharps injury prevention.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the PersonnaPlus Safety Scalpel System is a physical medical device (scalpel) with a mechanical safety feature, not an algorithm or AI. Its performance inherently involves human interaction (user handling).
7. The Type of Ground Truth Used
For the "simulated user study," the "ground truth" likely involved:
- Expert observation/assessment: Healthcare professionals or trained observers evaluating the proper use of the scalpel, the successful deployment of the safety feature, and the absence of simulated sharps injuries.
- Performance metrics related to sharps injury prevention: This would likely involve quantifiable outcomes like the number of successful activations of the safety mechanism, the rate of inadvertent exposures, or compliance with safe disposal protocols.
However, the document does not explicitly state the specific type of ground truth or how it was established beyond "a successful simulated user study."
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above (not an AI/algorithm).
{0}------------------------------------------------
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
-
- 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.
-
- 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.,
-
- 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.
{1}------------------------------------------------
| DeviceCharacteristics | K923170 Los AlamosRetractable Knife | PersonnaPlus Medical Safety Scalpeland 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 andre-sterilization of handle |
| Blade size(s) | 10, 11, 15 | Handle sizes 3, 4Blade 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 |
-
- Safety and Effectiveness, comparison to predicate device:
-
- 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
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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
{4}------------------------------------------------
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
§ 878.4800 Manual surgical instrument for general use.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.