(53 days)
The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in mininally invasive and/or open surgical procedures to facilitate cutting, preparation, mobilization and coagulation of tissue.
SterilMed's reprocessed scissor tips are laparoscopic electric devices that are inserted into a reusable hand piece and are designed to be used in laparoscopic and open surgical procedures to facilitate coagulation, preparation, mobilization and cutting of tissue. The devices are monopolar and have a cautery connector on the handle or a connector cable. These devices were originally manufactured by Aesculap (Braun), Encision, Microline, and Snowden Pencer. Note: Only the scissor tip is the subject of this submission, the reusable hand piece, the cautery cable and the generator are not included in the scope of this submission.
Here's an analysis of the provided text regarding the acceptance criteria and study for SterilMed's Reprocessed Scissor Tips.
However, it's important to note that the provided document is a 510(k) Premarket Notification Summary for a medical device reprocessing company. These submissions focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or safety through traditional clinical trials or AI performance metrics. Therefore, many of your requested points regarding AI, ground truth, and expert studies are not applicable to this type of regulatory submission and device.
This document primarily discusses functional and safety testing to ensure the reprocessed device performs like the original, new device.
Acceptance Criteria and Device Performance for Reprocessed Scissor Tips
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Characteristics | "Appropriate functional characteristics" (e.g., cutting ability, coagulation effectiveness, mechanical integrity, proper fit with handpiece) | "Representative samples of reprocessed scissor tips were tested to demonstrate appropriate functional characteristics." |
| Cleaning Procedures | Validation of cleaning effectiveness (e.g., removal of biological debris, prevention of cross-contamination) | "Process validation testing was performed to validate the cleaning... procedures." |
| Sterilization Procedures | Validation of sterilization effectiveness (e.g., achievement of sterility assurance level) | "Process validation testing was performed to validate the... sterilization procedures." |
| Device Packaging | Validation of packaging integrity (e.g., maintaining sterility, protection during transport) | "Process validation testing was performed to validate the... device packaging." |
| Visual Inspection | Meeting predefined visual quality standards (e.g., absence of damage, corrosion, residue) | "the manufacturing process includes visual and validated functional testing of all products produced." |
| Method of Construction | Maintaining material properties and design similarity to predicate devices. | "This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "Representative samples of reprocessed scissor tips were tested." No specific numerical sample size is provided. The types of scissor tips reprocessed are listed (Aesculap, Encision, Microline, Snowden Pencer, with several models each), suggesting samples were drawn from these variations.
- Data Provenance: The testing was performed by SterilMed, Inc. It is retrospective in the sense that the reprocessed devices are compared to the performance characteristics of the original new devices (predicates). The country of origin for the data generation would be the United States (Maple Grove, MN, where SterilMed is located).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document describes functional and process validation testing of physical medical devices, not a study involving human expert interpretation of data (like imaging or clinical diagnoses). "Ground truth" for these tests would likely involve objective measurements and established engineering/scientific standards rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human experts interpreting subjective data, an adjudication method for consensus is not relevant here. The testing involves objective measurements against established specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- Not Applicable. This is a regulatory submission for reprocessed surgical scissor tips, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. As above, this is not an AI-driven device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" implicitly used for the functional and safety testing of these reprocessed devices is the performance specifications and characteristics of the original, new predicate devices, as well as established engineering and scientific standards for cleaning, sterilization, and material integrity. For example, a "ground truth" for cutting ability would be that it must perform as well as a new scissor tip, and sterility "ground truth" would be an acceptable sterility assurance level (SAL).
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device and submission. The performance of the reprocessed devices is validated against the known performance of new devices, not by training an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
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Image /page/0/Picture/0 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."
FEB 1 2 2008 510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 20, 2007
For Reprocessed Scissor Tips (Laparoscopic Electric Instrument Accessories)
II. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Joshua Clarin11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 763-488-3483Fax: 763-488-3350 |
| Date Prepared: | December 17, 2007 |
| Trade Name: | Reprocessed Scissor Tips |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessory |
| Classification Number: | Class II, 21 CFR 878.4400 |
| Product Code: | NUJ |
| PredicateDevices: | The reprocessed scissor tips are substantially equivalent to Snowden Pencer Switchblade®,Microline Eversharp®, Aesculap Disposable Scissor Insert, and Encision AEM® Scissor Insertsterile electrosurgical scissors. |
|---|---|
| DeviceDescription: | SterilMed's reprocessed scissor tips are laparoscopic electric devices that are inserted into areusable hand piece and are designed to be used in laparoscopic and open surgical proceduresto facilitate coagulation, preparation, mobilization and cutting of tissue. The devices aremonopolar and have a cautery connector on the handle or a connector cable. These deviceswere originally manufactured by Aesculap (Braun), Encision, Microline, and Snowden Pencer.Note: Only the scissor tip is the subject of this submission, the reusable hand piece, the cauterycable and the generator are not included in the scope of this submission. |
| Intended Use: | The reprocessed scissor tips are intended to be used with a reusable hand piece and aredesigned for use in minimally invasive and open surgical procedures to facilitate coagulation,preparation, mobilization, and cutting of tissue. |
| Functional andSafety Testing: | Representative samples of reprocessed scissor tips were tested to demonstrate appropriatefunctional characteristics. Process validation testing was performed to validate the cleaning andsterilization procedures as well as device packaging. In addition, the manufacturing processincludes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed Scissor Tips are substantially equivalent to Snowden Pencer Switchblade®,Microline Eversharp®, Aesculap Disposable Scissor Insert, and Encision AEM® Scissor Insertsterile electrosurgical scissors.This conclusion is based upon the devices' similarities in functional design (principle ofoperation), materials, indications for use and methods of construction. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2008
SterilMed, Inc. % Mr. Joshua Clarin Senior Regulatory Affairs Specialist 11400 73td Avenue North, Suite 100 Maple Grove, Minnesota 55369
Re: K073613
Trade/Device Name: Reprocessed Scissor Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: December 20, 2007 Received: December 21, 2007
Dear Mr. Clarin:
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
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Page 2 – Mr. Joshua Clarin
forth in the quality systems (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 acre ventures (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 Assistances of at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 20, 2007
For Reprocessed Scissor Tips (Laparoscopic Electric Instrument Accessories)
K0 73613
Indications for Use
510(k) Number (if known):
Device Name: Reprocessed Scissor Tips
Indications for Use:
The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in mininally invasive and/or open surgical procedures to facilitate cutting, preparation, mobilization and coagulation of tissue.
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)
Division of General Restorative. and Neurological Devices
510(k) Number L073613
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
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| Manufacturer | Model # | Description |
|---|---|---|
| Aesculap(Braun) | PO886 | Hook Scissor Tip, 5mm diameter,31 cm long |
| PO887 | Mini-Metzenbaum Scissor Tip,5mm diameter, 31 cm long | |
| PO888 | Metzenbaum Scissor Tip, 5mmdiameter, 31 cm long | |
| PO889 | Metzenbaum Scissor Tip, 5mmdiameter, 42 cm long | |
| Encision | ES0101 | Curved Scissor Tip ½", 35cm long |
| ES0102 | Curved Scissor Tip ¾, 35cm long | |
| ES0110 | Hook Scissor Tip. 35cm long | |
| Microline | 3112 | Scissor Tip Metzenbaum 13.46 mm long |
| 3122 | Scissor Tip Micro 9.4 mm long | |
| 3132 | Scissor Tip Hook 12.7 mm long | |
| 3142 | Scissor Tip Endocut 16.51 mm long | |
| 3152 | Scissor Tip Mini Endocut 11.42mm long | |
| SnowdenPencer | 89-5100 | Scissor Tip Curved |
| 89-5200 | Scissor Tip Hook | |
| 89-5300 | Scissor Tip Curved Mini-Metzenbaum Micro |
:
:
100 - 100 - 100
The following table displays the list of the fifteen (15) Reprocessed Scissors included in this subject K073613 submission: Tips
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:
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.