(102 days)
The reprocessed vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectory, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The reprocessed vessel sealer/dividers can be used to on vessels and lymphatics up to and including 7 mm, and tissue bundles.
The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.
The provided text describes a 510(k) premarket notification for a reprocessed vessel sealer, focusing on its substantial equivalence to a predicate device. The information details functional and safety testing to support this claim, rather than a clinical study evaluating AI performance or human reader improvements. Therefore, some of the requested information regarding AI-specific assessments (like MRMC studies, standalone AI performance, or training set details) will not be present in this document.
Here's an breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of "acceptance criteria" alongside specific "reported device performance" values for each criterion in a quantitative format as one might expect for a typical diagnostic device study. Instead, it lists the types of tests performed and generally states that the device performs "as originally intended."
| Acceptance Criteria Category (Derived) | Stated Performance / Testing Focus |
|---|---|
| Cleaning & Sterilization | Process validation performed to validate cleaning and sterilization procedures. Specific tests: Cleaning validation, Sterilization validation (ISO 11135, USP <71>), Ethylene oxide residual testing (ISO 10993-7). |
| Packaging & Shelf-life | Process validation performed for device packaging. Specific tests: Packaging validation (ASTM D4169, ASTM F88, ASTM F2096), Shelf-life validation (ASTM 1980-07). |
| Functional Performance | Functional testing performed through simulated use, visual inspection, and fatigue testing. Manufacturing process includes visual and validated functional testing of all products. Specific tests: Electrical Safety (IEC 60601-2-2), Device Functionality, Vessel Seal Burst (Static and Burst Pressure), Vessel Seal Thermal Spread, Mold Stress, Drop, Spillage, Push. Reported Outcome: "Performance testing shows the reprocessed vessel sealers to perform as originally intended." and "The reprocessed vessel sealer has the same technological and performance characteristics as the predicate, K130744." |
| Biocompatibility | Ethylene oxide residual testing (ISO 10993-7) implies compliance with biocompatibility standards related to sterilization residuals. (No explicit statement of full biocompatibility testing beyond residual testing from what is provided). |
2. Sample size used for the test set and the data provenance
The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for any of the test sets (e.g., number of devices used for burst pressure, thermal spread, or fatigue testing).
The data provenance is from non-clinical tests performed by SterilMed, Inc. (and Libra Medical Inc. for contact purposes). This is a manufacturer's submission for regulatory approval, implying the data was generated internally for this purpose. The country of origin for the testing would presumably be the country of the manufacturing/testing facility, which is stated as "11400 73rd Avenue North Maple Grove, MN 55369" (USA). The testing is retrospective in the sense that it's performed on batches of reprocessed devices to demonstrate consistent quality and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this type of device (a reprocessed surgical instrument) is established through engineering and scientific performance testing against defined physical and electrical standards, not through expert clinical consensus as would be common for diagnostic or AI-driven devices.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) where experts may disagree, requiring a method to reach a consensus "ground truth." For engineering performance tests, the results are quantitative and objective, not subject to expert disagreement requiring adjudication in this context.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a reprocessed electrosurgical device, not an AI-based diagnostic tool or system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm or AI.
7. The type of ground truth used
The ground truth used for this device is based on engineering standards, physical measurements, and compliance with predicate device performance characteristics. This includes:
- Pre-defined physical and electrical specifications (e.g., IEC 60601-2-2 for electrical safety).
- Validation against established protocols for cleaning, sterilization, packaging, and shelf-life (e.g., ISO 11135, USP <71>, ISO 10993-7, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-07).
- Functional performance benchmarks, such as vessel seal burst pressure, thermal spread, and mechanical integrity, designed to demonstrate equivalence to the original (predicate) device's intended performance.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized image of three human profiles facing right, with a design that resembles an abstract bird or wing above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2015
SterilMed % Dr. Sew-Wah Tay Libra Medical 8401 73rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428
Re: K143260
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: January 23, 2015 Received: January 26, 2015
Dear Dr. Tay:
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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Dr. Sew-Wah Tay
Device Models Subject to Clearance:
| ModelNumber | Device Description | ShaftDiameter | ShaftLength | ShaftRotation |
|---|---|---|---|---|
| LF1637 | Reprocessed Covidien Ligasure 5 mm,Blunt Tip, LaparoscopicSealer/Divider | 5 mm | 37 cm | 180° |
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Indications for Use
510(k) Number (if known) K143260
Device Name
Reprocessed Vessel Sealers
Indications for Use (Describe)
The reprocessed vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectory, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The reprocessed vessel sealer/dividers can be used to on vessels and lymphatics up to and including 7 mm, and tissue bundles.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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II. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter and Manufacturer: | Nicole BoserSterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446 |
|---|---|
| Manufacturing FacilityAddress: | 11400 73rd Avenue NorthMaple Grove, MN 55369 |
| Primary Contact: | Sew-Wah Tay PhDLibra Medical, Inc.Tel: 612-801-6782Fax: 763-477-6357Email: swtay@libramed.com |
| Secondary Contacts: | Nicole BoserTel: (763) 488-2050Fax: (763) 488-3441Email: nboser@sterilmed.com |
| Date of Submission: | 12 November 2014 |
| Trade Name: | Reprocessed Vessel Sealer |
| Regulation Name: | Electrosurgical, cutting & coagulation accessories,laparoscopic & endoscopic, reprocessed |
| Regulation Number | 21 CFR 878.4400 |
| Device Classification: | Class II |
| Product Code: | NUJ |
| Predicate Devices: | Covidien LigaSure™ 5 mm, Blunt Tip Laparoscopic Sealer/Divider (K130744).Sterilmed Reprocessed Vessel Sealer (K123096) |
|---|---|
| Device Description: | The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgicalinstrument designed exclusively for use with the ForceTriad™ energy platform(generator) to ligate (seal) and divide (cut) vessels, tissue bundles, andlymphatics clamped between the jaws, grasping tissue, and blunt dissectionduring laparoscopic general surgical procedures (as indicated) using radiofrequency (RF) energy. A hand actuated lever allows the user to open and closethe instrument jaws, and includes a latching mechanism that holds the jaws in theclosed position during vessel sealing and cutting. |
| Intended Use: | The reprocessed vessel sealer/dividers are intended for use in general andgynecological laparoscopic surgical procedures where ligation anddivision of vessels and lymph is desired.Indications for use include general laparoscopic procedures includingurologic, vascular, thoracic and thoracoscopic, and gynecologicprocedures where ligation and division of the vessels is performed. Theseprocedures include laparoscopically assisted vaginal hysterectomy, Nissenfundoplication, colectomy, adhesiolysis, oophorectomy, etc. The devicehas not been shown to be effective for tubal sterilization or tubalcoagulation for sterilization procedures, and should not be used for these procedures.The reprocessed vessel sealer/dividers can be used to on vessels andlymphatics up to and including 7 mm, and tissue bundles. |
| TechnologicalCharacteristics: | The reprocessed vessel sealer has the same technological and performancecharacteristics as the predicate, K130744. Similar to the predicate, thisreprocessed device seals vessels and lymphatics using radio frequency (RF)energy to achieve its intended use and can mechanically divide the sealed areasor tissue with a mechanical cutting device. The manner of reprocessing andtesting is identical to predicate K123096, Sterilmed reprocessed vessel sealer. |
| Functional andSafety Testing: | Representative samples of reprocessed devices were tested to demonstrateappropriate functional characteristics. Process validation testing was performedto validate the cleaning and sterilization procedures as well as device packaging.In addition, the manufacturing process includes visual and validated functionaltesting of all products produced. |
| Summary ofNon-clinical TestsConducted: | Specific non-clinical tests performed included: cleaning validation, sterilizationvalidation (ISO 11135, USP <71>), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf-life validation (ASTM 1980-07). In addition, validation of functionalperformance (bench testing) was performed through simulated use, visualinspection, and fatigue testing. Testing performed:• Electrical Safety (IEC 60601-2-2)• Device Functionality• Vessel Seal Burst (Static and Burst Pressure)• Vessel Seal Thermal Spread• Mold Stress• Drop• Spillage• PushPerformance testing shows the reprocessed vessel sealers to perform asoriginally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed vessel sealer is safe, effective, andsubstantially equivalent to the predicate device, Covidien LigaSure™ 5 mm,Blunt Tip, Laparoscopic Sealer/Divider (K130744), as described in thispremarket notification submission. The reprocessing and validation methodsused are similar to the Sterilmed reprocessed vessel sealer predicate device(K123096). |
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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.