(168 days)
The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the iaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, 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 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 general surgical procedures (as indicated), laparoscopic or open, using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSureTM mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.
This document describes the regulatory clearance for reprocessed vessel sealers (device name: Reprocessed Vessel Sealers, models LF1737 and LF1723) which are electrosurgical instruments. The submission aims to demonstrate substantial equivalence to predicate devices (Covidien LigaSure™ 5 mm, Maryland Jaw Sealer/Dividers, K133338).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way one might expect for an AI/CADe device. Instead, the acceptance criteria are implicitly defined by a series of non-clinical tests designed to demonstrate that the reprocessed devices perform as intended and are safe and effective, similar to the original predicate devices. The reported device performance is generally stated as achieving compliance with these tests.
However, based on the "Summary of Non-Clinical Tests Conducted" section, we can infer the following:
| Acceptance Criteria (Inferred from Tests) | Reported Device Performance (Summary) |
|---|---|
| Cleaning Validation: | Validated cleaning procedures. |
| Sterilization Verification: | Validated sterilization procedures. |
| Ethylene Oxide Residual Testing: | Compliant with ISO 10993-7. |
| Packaging Validation: | Compliant with ASTM D4169, ASTM F88, ASTM F2096. |
| Shelf-Life Validation: | Compliant with ASTM 1980-07. |
| Visual Inspection: | Part of manufacturing process and bench testing to demonstrate appropriate functional characteristics. |
| Fatigue Testing: | Performed as part of functional performance (bench testing). |
| Electrical Safety: | Testing performed. |
| Device Functionality: | Testing performed. |
| Vessel Seal Burst (Static and Burst Pressure): | Testing performed. Performance shows reprocessed vessel sealers perform as originally intended. |
| Vessel Seal Thermal Spread: | Testing performed. |
| EMC: | Testing performed. |
| Mold Stress: | Testing performed. |
| Drop: | Testing performed. |
| Spillage: | Testing performed. |
| Push: | Testing performed. |
| Biocompatibility: | Testing performed for Cytotoxicity, Pyrogen, Thrombogenicity, Irritation, Acute Toxicity, Immune Response, Hemolysis, Sensitization. |
Overall Conclusion: "Performance testing shows the reprocessed vessel sealers to perform as originally intended." and "Sterilmed concludes that the reprocessed vessel sealers are safe, effective, and substantially equivalent to the predicate devices..."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions that "Representative samples of reprocessed devices were tested" for various functional and safety characteristics. However, specific sample sizes (e.g., number of devices, number of seals, number of tests for each parameter) for each test are not provided.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be bench and laboratory testing performed by the manufacturer/reprocessor (Sterilmed, Inc., located in Minnesota, USA). The nature of these tests (cleaning, sterilization, packaging, functional performance, biocompatibility) indicates they are prospective tests performed on manufactured devices, not retrospective data analysis from clinical cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable as the device is a reprocessed surgical instrument, not an AI/CADe device or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., burst pressure thresholds, sterility levels, biocompatibility profiles) and comparison to the performance of the original device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human readers or AI outputs. The tests described are objective engineering and laboratory tests where the outcome is determined by adherence to a predefined standard or measurement, not by expert consensus or adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance, especially for AI-assisted image interpretation. The device in question is a reprocessed surgical instrument, and its performance is evaluated through bench testing and safety assessments, not through human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is not an algorithm or AI system. It is a physical medical instrument. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on objective engineering standards, validated laboratory testing protocols, and comparison to the established performance of the original, new device. For example:
- Sterility: Absence of microorganisms, verified by sterilization indicators and microbial testing.
- Ethylene Oxide Residuals: Concentrations below a specified limit (ISO 10993-7).
- Mechanical Functionality: Ability to open, close, grasp, seal, and cut within specified force ranges and dimensions, often compared to the original device's specifications.
- Vessel Seal Burst Strength: Ability to withstand a certain pressure without leaking (e.g., specified kPa or mmHg).
- Electrical Safety: Compliance with electrical safety standards (e.g., leakage current, insulation).
- Biocompatibility: Absence of adverse biological reactions (cytotoxicity, irritation, etc.) validated through in vitro and in vivo tests.
Essentially, the ground truth is established by meeting predefined scientific and engineering thresholds that demonstrate the device is safe and performs identically or equivalently to the original device.
8. The sample size for the training set
This section is not applicable. The device is a physical reprocessed medical instrument, not an AI model. Therefore, there is no "training set" in the context of machine learning. The "training" for the reprocessing procedures involves process validation and adherence to established protocols for cleaning, sterilization, and functional testing.
9. How the ground truth for the training set was established
This section is not applicable as there is no "training set" in the machine learning sense. However, if one were to loosely interpret "training set" as the data that informed the reprocessing procedures and quality checks, then the "ground truth" for establishing these procedures would be derived from:
- Regulatory standards: Follow FDA guidelines and relevant international standards (e.g., ISO for sterilization, biocompatibility).
- Manufacturer's specifications: Understanding the original device's design, materials, and performance requirements.
- Scientific and engineering principles: Applying established methods for cleaning, disinfection, sterilization, and material compatibility.
- Validation studies: Performing rigorous studies to prove that the reprocessing methods consistently achieve the desired outcomes (e.g., sterility, functionality).
The "ground truth" in this context is the successful demonstration that the reprocessed device can consistently meet the same safety and performance characteristics as the new, original device.
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
Sterilmed Incorporated % Ming Cheng Chew Libra Medical 8401 73rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428
Re: K152134
Trade/Device Name: Reprocessed Vessel Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: December 15, 2015 Received: December 16, 2015
Dear Ming Cheng Chew:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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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" (21 CFR 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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| Device Model | Device Name | Original Manufacturer |
|---|---|---|
| LF1737 | Reprocessed LigaSure 5mm Maryland JawSealer/Divider, 37cm shaft, used withForceTriad energy platform | Covidien |
| LF1723 | Reprocessed LigaSure 5mm Maryland JawSealer/Divider, 23cm shaft, used withForceTriad energy platform | Covidien |
Reprocessed Single-Use Device Models Included in Clearance:
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed Vessel Sealers
Includes the LF1737 and LF1723 models
Indications for Use (describe)
The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the iaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, 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 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 (Part 21 CFR 801Subpart C |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
| Submitter andManufacturer: | Patricia F. KaufmanSterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446 |
|---|---|
| Manufacturing FacilityAddress: | 11400 73rd Avenue NorthMaple Grove, MN 55369 |
| Primary Contact: | Ming-Cheng ChewLibra Medical, Inc.Tel: 763-232-3701Fax: 763-477-6357Email: mcchew@libramed.com |
| Secondary Contact: | Julie BodmerLibra Medical, Inc.Tel: 612-910-3412Fax: 763-477-6357Email: jbodmer@libramed.com |
| Date of Submission: | 30 July 2015 |
| 510(k) Number | K152134 |
| Trade Name: | Reprocessed Vessel Sealers |
| Regulation Name: | Electrosurgical, cutting & coagulationaccessories, laparoscopic & endoscopic,reprocessed |
| Device Classification: | Class II |
| Device Regulation: | 878.4400 |
| Product Code: | NUJ |
| Predicate Device: | Covidien LigaSure™ 5 mm, Maryland Jaw Sealer/Dividers (K133338). |
|---|---|
| DeviceDescription: | The reprocessed vessel sealer is a sterile, hand-held bipolar RFelectrosurgical instrument designed exclusively for use with theForceTriad™ energy platform (generator) to ligate (seal) and divide (cut)vessels, tissue bundles, and lymphatics clamped between the jaws, graspingtissue, and blunt dissection during general surgical procedures (asindicated), laparoscopic or open, using radio frequency (RF) energy. Ahand actuated lever allows the user to open and close the instrument jawswithout having to latch the lever, which includes a clicking mechanism thatindicates to the user that the jaws are in the grasping zone, a button |
| (switch) to activate the LigaSureTM mode by closing the handle against thebutton (switch) for vessel sealing, and a trigger to actuate an independentcutting blade. | |
| Indications forUse: | The reprocessed vessel sealer/dividers are bipolar electrosurgicalinstruments intended for use with the ForceTriadTM Energy Platform ingeneral, minimally invasive and open surgical procedures where ligationand division of vessels and lymphatics is desired. The instrument creates aseal by application of RF electrosurgical energy to vascular structures(vessels and lymphatics) interposed between the jaws of the instrument.A blade within the instrument is surgeon actuated to divide tissue. |
| Indications for use include general open and minimally invasiveprocedures including urologic, vascular, thoracic and thoracoscopic, andgynecologic procedures where ligation and division of the vessels isperformed. These procedures include: laparoscopically assisted vaginalhysterectomy, Nissen fundoplication, colectomy, adhesiolysis,oophorectomy, etc. The device has not been shown to be effective fortubal sterilization or tubal coagulation for sterilization procedures, andshould not be used for these procedures. | |
| The reprocessed vessel sealer/dividers can be used on vessels andlymphatics up to and including 7 mm, and tissue bundles. | |
| TechnologicalCharacteristics: | The reprocessed vessel sealers have the same technological andperformance characteristics as the predicates LF1723 and LF1737,K133338. Similar to the predicate models, each of these reprocesseddevices seal vessels and lymphatics using radio frequency (RF) energy toachieve intended use and can mechanically divide the sealed areas or tissuewith a mechanical cutting device. |
| Models Included inthis Submission | LF1737 - Reprocessed Covidien LigaSureTM 5mm Maryland JawSealer/Divider, 37cm shaft, used with ForceTriadTM energy platformLF1723 - Reprocessed Covidien LigaSureTM 5mm Maryland JawSealer/Divider, 23cm shaft, used with ForceTriadTM energy platform |
| Functional andSafety Testing: | Representative samples of reprocessed devices were tested to demonstrateappropriate functional characteristics. Process validation testing wasperformed to validate the cleaning and sterilization procedures as well asdevice packaging. In addition, the manufacturing process includes visualand validated functional testing of all products produced. |
| Summary ofNon-Clinical TestsConducted: | Specific non-clinical tests performed included: cleaning validation,sterilization verification, ethylene oxide residual testing (ISO 10993-7),packaging validation (ASTM D4169, ASTM F88, ASTM F2096), andshelf-life validation (ASTM 1980-07). In addition, validation of functional |
| performance (bench testing) was performed through visual inspection, andfatigue testing. Testing performed:• Electrical Safety• Device Functionality• Vessel Seal Burst (Static and Burst Pressure)• Vessel Seal Thermal Spread• EMC• Mold Stress• Drop• Spillage• PushPerformance testing shows the reprocessed vessel sealers to perform asoriginally intendedBiocompatibility testing for the following parameters were alsoperformed:• Cytotoxicity• Pyrogen• Thrombogenicity• Irritation• Acute Toxicity• | |
| • Immune Response• Hemolysis• | |
| • Sensitization• | |
| Conclusion: | Sterilmed concludes that the reprocessed vessel sealers are safe, effective,and substantially equivalent to the predicate devices, Covidien LigaSure™5 mm, Maryland Jaw Sealer/Dividers Models LF1723 and LF1737(K133338), as described in this premarket notification submission. |
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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.