(168 days)
Not Found
No
The summary describes a reprocessed electrosurgical instrument for vessel sealing and division, focusing on mechanical and electrical functions. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a surgical instrument used for cutting and sealing vessels during surgical procedures, which is an intervention or diagnostic tool, not a therapeutic device designed for treatment or rehabilitation.
No.
Explanation: The device is an electrosurgical instrument for sealing and dividing vessels, not for diagnosing medical conditions. Its intended use and functions describe surgical intervention, not diagnostic evaluation.
No
The device description clearly outlines a physical, hand-held bipolar RF electrosurgical instrument with mechanical components (jaws, lever, button, trigger, blade) and relies on RF energy for its function, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a surgical instrument used during surgical procedures to seal and divide vessels and tissue within the body. It uses RF energy and a cutting blade.
- Intended Use: The intended use is for surgical procedures where ligation and division of vessels and lymphatics are desired. This is an in vivo (within the living organism) application, not in vitro (in glass or outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of samples, diagnostic testing, or providing information for diagnosis based on bodily fluids or tissues.
Therefore, this device falls under the category of a surgical instrument used for therapeutic and procedural purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NUJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels and lymphatics; urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
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), and shelf-life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through visual inspection, and fatigue testing. Testing performed:
• Electrical Safety
• Device Functionality
• Vessel Seal Burst (Static and Burst Pressure)
• Vessel Seal Thermal Spread
• EMC
• Mold Stress
• Drop
• Spillage
• Push
Performance testing shows the reprocessed vessel sealers to perform as originally intended
Biocompatibility testing for the following parameters were also performed:
• Cytotoxicity
• Pyrogen
• Thrombogenicity
• Irritation
• Acute Toxicity
• Immune Response
• Hemolysis
• Sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
| Device Model | Device Name | Original Manufacturer |
|---|---|---|
| LF1737 | Reprocessed LigaSure 5mm Maryland Jaw | |
| Sealer/Divider, 37cm shaft, used with | ||
| ForceTriad energy platform | Covidien | |
| LF1723 | Reprocessed LigaSure 5mm Maryland Jaw | |
| Sealer/Divider, 23cm shaft, used with | ||
| ForceTriad energy platform | Covidien |
Reprocessed Single-Use Device Models Included in Clearance:
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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 801 |
| Subpart C | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
This section applies only to requirements of the Paperwork Reduction Act of 1995 *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
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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."
5
510(k) Summary
| Submitter and
Manufacturer: | Patricia F. Kaufman
Sterilmed, Inc.
5010 Cheshire Parkway N, Suite 2
Plymouth, MN 55446 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Manufacturing Facility
Address: | 11400 73rd Avenue North
Maple Grove, MN 55369 |
| Primary Contact: | Ming-Cheng Chew
Libra Medical, Inc.
Tel: 763-232-3701
Fax: 763-477-6357
Email: mcchew@libramed.com |
| Secondary Contact: | Julie Bodmer
Libra Medical, Inc.
Tel: 612-910-3412
Fax: 763-477-6357
Email: jbodmer@libramed.com |
| Date of Submission: | 30 July 2015 |
| 510(k) Number | K152134 |
| Trade Name: | Reprocessed Vessel Sealers |
| Regulation Name: | Electrosurgical, cutting & coagulation
accessories, 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). |
|---|---|
| Device | |
| Description: | 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. | |
| Indications for | |
| Use: | The reprocessed vessel sealer/dividers are bipolar electrosurgical |
| instruments intended for use with the ForceTriadTM 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 jaws 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. | |
| Technological | |
| Characteristics: | The reprocessed vessel sealers have the same technological and |
| performance characteristics as the predicates LF1723 and LF1737, | |
| K133338. Similar to the predicate models, each of these reprocessed | |
| devices seal vessels and lymphatics using radio frequency (RF) energy to | |
| achieve intended use and can mechanically divide the sealed areas or tissue | |
| with a mechanical cutting device. | |
| Models Included in | |
| this Submission | LF1737 - Reprocessed Covidien LigaSureTM 5mm Maryland Jaw |
| Sealer/Divider, 37cm shaft, used with ForceTriadTM energy platform | |
| LF1723 - Reprocessed Covidien LigaSureTM 5mm Maryland Jaw | |
| Sealer/Divider, 23cm shaft, used with ForceTriadTM energy platform | |
| Functional and | |
| Safety Testing: | Representative samples of reprocessed devices were tested to demonstrate |
| appropriate functional characteristics. Process validation testing was | |
| performed to validate the cleaning and sterilization procedures as well as | |
| device packaging. In addition, the manufacturing process includes visual | |
| and validated functional testing of all products produced. | |
| Summary of | |
| Non-Clinical Tests | |
| Conducted: | 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), and | |
| shelf-life validation (ASTM 1980-07). In addition, validation of functional | |
| performance (bench testing) was performed through visual inspection, and | |
| fatigue testing. Testing performed: | |
| • Electrical Safety | |
| • Device Functionality | |
| • Vessel Seal Burst (Static and Burst Pressure) | |
| • Vessel Seal Thermal Spread | |
| • EMC | |
| • Mold Stress | |
| • Drop | |
| • Spillage | |
| • Push | |
| Performance testing shows the reprocessed vessel sealers to perform as | |
| originally intended | |
| Biocompatibility testing for the following parameters were also | |
| performed: | |
| • 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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