(115 days)
The reprocessed vessel sealers are indicated for use in general and gynecological, laparoscopic surgical prooedures where ligation of vasculature is desired. The reprocessed vessel sealers can be used to seal to seal to seal to seal and including 7 imm, lymphatics, and tissue bundles. The reprocessed vessel scalers can also be used to seal pulmonary vasculature when used with the ForceTriad™ energy platform.
The vessel sealers are electrosurgical instruments for use with the ForceTriad™ energy platform when performing laparoscopic procedures. The vessel sealers are capable of sealing vessels and lymphatics, grasping tissue and dissection. The vessel sealers have a 5 mm shaft diameter, 37 cm shaft length and a shaft rotation of 159 degrees. The distal end mechanism may have a blunt or dolphin nose tip.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Vessel Sealers:
Based on the provided information, this submission focuses on the substantial equivalence of a reprocessed medical device to its original predicate devices, rather than a novel device requiring a typical clinical study with acceptance criteria for efficacy. The "acceptance criteria" here therefore refers to demonstrating that the reprocessed device performs identically to the predicate device and meets established safety and functional standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Performance identical to predicate devices in design, materials, clinical applications, patient population, performance specifications, and method of operation. | "The reprocessed vessel sealers are identical to the predicate devices in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation." "Performance testing shows the reprocessed vessel sealers to perform as originally intended." |
| Cleaning Validation | Validation of cleaning procedures. | "Process validation testing was performed to validate the cleaning... procedures." Specific details of acceptance metrics for cleaning are not provided, but it's stated as validated. |
| Sterilization Validation | Validation of sterilization procedures (ISO 11135, USP <71>). | "Process validation testing was performed to validate the ... sterilization procedures." Adherence to ISO 11135 and USP <71> implies meeting their respective sterility assurance level (SAL) requirements. |
| Biocompatibility | Assurance of biocompatibility (ISO 10993). | "Biocompatibility testing (ISO 10993)" was performed. Adherence to ISO 10993 implies meeting its requirements for biological safety. |
| Ethylene Oxide Residuals | Testing for ethylene oxide residuals (ISO 10993-7). | "Ethylene oxide residual testing (ISO 10993-7)" was performed. Adherence to ISO 10993-7 implies meeting its requirements for acceptable residual levels. |
| Packaging Validation | Validation of packaging (ASTM D.4169, ASTM F 88, ASTM F 2096). | "Packaging validation (ASTM D.4169, ASTM F 88, ASTM F 2096)" was performed. Adherence to these ASTM standards implies meeting requirements for package integrity and sterile barrier maintenance. |
| Shelf Life Validation | Validation of shelf life (ASTM 1980-07). | "Shelf life validation (ASTM 1980-07)" was performed. Adherence to ASTM 1980-07 implies meeting requirements for maintaining sterility and functionality over the declared shelf life. |
| Functional Performance | Demonstrated appropriate functional characteristics; bench testing through simulated use, visual inspection, fatigue testing, and function testing. | "Representative samples of reprocessed vessel sealers were tested to demonstrate appropriate functional characteristics." "validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing." This indicates the device met pre-defined functional requirements, though specific metrics are not detailed. |
| Manufacturing Process | Includes visual and validated functional testing of all products produced. | "the manufacturing process includes visual and validated functional testing of all products produced." This is an ongoing quality control measure to ensure individual units meet standards. |
2. Sample Size and Data Provenance
The document does not explicitly state specific sample sizes for each non-clinical test (e.g., how many reprocessed devices were tested for cleaning validation). It refers to "Representative samples" for functional testing.
- Test Set Sample Size: Not explicitly stated for specific tests, but general reference to "representative samples."
- Data Provenance: The studies are described as internal non-clinical tests performed by Sterilmed, Inc. (submitter). The country of origin for the data is implicitly the USA, where Sterilmed is located and where the submission was made to the FDA. The data is prospective in the sense that these tests were conducted by Sterilmed for the purpose of this 510(k) submission to demonstrate equivalence.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (reprocessed device) primarily relies on engineering and laboratory test standards rather than expert interpretation of clinical data or images. Therefore, the concept of "ground truth established by experts" as seen in diagnostic AI is not directly applicable here. The "experts" would be the engineers, microbiologists, and other technical specialists who conducted and validated the non-clinical tests according to established international and national standards (e.g., ISO, ASTM, USP). Their qualifications would be expertise in those particular testing methodologies and standards.
4. Adjudication Method
Not applicable. This is not a study involving human reader interpretation or clinical outcomes requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a submission for a reprocessed medical device demonstrating equivalence through non-clinical testing. It does not involve AI, human reader performance, or clinical comparative effectiveness studies in the traditional sense of a novel diagnostic or therapeutic device.
6. Standalone Performance Study
Yes, in a sense. The "standalone performance" is demonstrated through the various non-clinical tests (cleaning, sterilization, biocompatibility, functional performance, etc.) where the reprocessed device is tested in isolation against defined criteria and regulatory standards. The purpose is to show the device performs on its own, as originally intended, after reprocessing.
7. Type of Ground Truth Used
The ground truth used in this context is predominantly:
- Engineering/Performance Standards: Adherence to established performance specifications (e.g., sealing capability, fatigue resistance, visual inspection criteria, shaft rotation).
- Regulatory/Industry Standards: Compliance with international and national standards for sterility (ISO 11135, USP <71>), biocompatibility (ISO 10993), packaging (ASTM D.4169, ASTM F 88, ASTM F 2096), shelf life (ASTM 1980-07), and residual chemicals (ISO 10993-7).
- Predicate Device Performance: The original functional specifications and performance of the predicate Covidien LigaSure™ Laparoscopic Instruments serve as the benchmark for "as originally intended" performance.
8. Sample Size for the Training Set
Not applicable. This is a reprocessed device submission based on non-clinical testing, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model in this submission.
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STERILMED.
510(K) PREMARKET NOTIFICATION SUBMISSION 01 OCTOBER 2012 For Reprocessed Vessel Sealers
for Reprocessed Vessel Sealers
II. SUMMARY AND CERTIFICATION
- A. 510(k) Summary
| Submitter: | Sterilmed, Inc. |
|---|---|
| Contact Person: | Jason Skramsted |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Phone: 763-488-3483 | |
| Fax: 763-488-4491 | |
| Date Prepared: | 01 October 2012 |
| Trade Name: | Reprocessed Vessel Sealers |
| Regulation Name: | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Regulation Number: | 21 CFR 878.4400 |
| Regulatory Class: | Class II |
| Product Code: | NUJ |
| JAN 2 5 2013 |
|---|
| -------------- |
K 123096
、
| PredicateDevices: | The reprocessed vessel sealers are substantially equivalent to the Covidien LigaSure™ LaparoscopicInstruments (K092879 and K031011). |
|---|---|
| DeviceDescription: | The vessel sealers are electrosurgical instruments for use with the ForceTriad™ energy platform whenperforming laparoscopic procedures. The vessel sealers are capable of sealing vessels and lymphatics,grasping tissue and dissection. The vessel sealers have a 5 mm shaft diameter, 37 cm shaft length and a shaftrotation of 159 degrees. The distal end mechanism may have a blunt or dolphin nose tip. |
| Intended Use: | The reprocessed vessel sealers are indicated for use in general and gynecological, laparoscopic surgicalprocedures where ligation of vasculature is desired. The reprocessed vessel sealers can be used to seal vesselsup to and including 7 min, lymphatics, and tissue bundles. The reprocessed vessel sealers can also be used toseal pulmonary vasculature when used with the ForceTriad™ energy platform. |
| TechnologicalCharacteristics: | The reprocessed vessel sealers are identical to the predicate devices in design, materials of construction, andintended use. There are no changes to the clinical applications, patient population, performancespecifications, or method of operation. |
| Functional andSafety Testing: | Representative samples of reprocessed vessel sealers were tested to demonstrate appropriate functionalcharacteristics. Process validation testing was performed to validate the cleaning and sterilization proceduresas well as device packaging. In addition, the manufacturing process includes visual and validated functionaltesting of all products produced. |
| Summary ofNon-clinicalTestsConducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<71>), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packagingvalidation (ASTM D.4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980-07). Inaddition, validation of functional performance (bench testing) was performed through simulated use, visualinspection, fatigue testing, and function testing. Performance testing shows the reprocessed vessel sealers toperform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed vessel sealers are safe, effective, and substantially equivalent to thepredicate devices, Covidien LigaSure™ Laparoscopic Instruments (K092879 and K031011), as described inthis premarket notification submission. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 25, 2013
SterilMed, Incorporated % Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73td Avenue North Maple Grove, Minnesota 55369
Re: K123096
Trade/Device Name: Reprocessed Vessel Sealers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: December 21, 2012 Received: December 26, 2012
Dear Mr. Skramsted:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jason Skramsted
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Reprocessed Vessel Sealers
Indications for Use:
The reprocessed vessel seaters are indicated for use in general and gynecological, laparoscopic surgical prooedures where ligation of vasculature is desired. The reprocessed vessel sealers can be used to seal to seal to seal to seal and including 7 imm, lymphatics, and tissue bundles. The reprocessed vessel scalers can also be used to seal pulmonary vasculature when used with the ForceTriad™ energy platform.
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)
Brian D. Pullin -S
2013.01.25, 13:14:29 -05'00'
Division of Surgical Devices 510(k) Number: K123096
§ 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.