(102 days)
Not Found
No
The device description and performance studies focus on electrosurgical function and reprocessing validation, with no mention of AI or ML.
No
The device is described as an electrosurgical instrument for sealing and dividing vessels and tissue during surgical procedures, not for treating or rehabilitating a disease or condition.
No
The device is described as an electrosurgical instrument for sealing and dividing vessels, not for diagnosing medical conditions.
No
The device description clearly states it is a "sterile, hand-held bipolar RF electrosurgical instrument" and describes physical components like jaws, a lever, and a latching mechanism. This indicates it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is a surgical instrument used during surgical procedures to seal and divide vessels and tissue within the body.
- The device description focuses on surgical function. The description details how the device works with an energy platform to perform surgical actions (sealing and cutting) on tissue.
- The performance studies are related to surgical device function and safety. The studies mentioned (cleaning, sterilization, electrical safety, vessel sealing performance, etc.) are typical for surgical instruments, not for devices that analyze biological samples.
In summary, this device is a surgical instrument used for therapeutic purposes during surgery, not a device used to diagnose conditions by examining samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), 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 simulated use, visual inspection, 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
• Push
Performance testing shows the reprocessed vessel sealers to perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Covidien LigaSure™ 5 mm, Blunt Tip Laparoscopic Sealer/Divider (K130744), Sterilmed Reprocessed Vessel Sealer (K123096)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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:
| Model
Number | Device Description | Shaft
Diameter | Shaft
Length | Shaft
Rotation |
|-----------------|----------------------------------------------------------------------------------|-------------------|-----------------|-------------------|
| LF1637 | Reprocessed Covidien Ligasure 5 mm,
Blunt Tip, Laparoscopic
Sealer/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 Boser
Sterilmed, Inc.
5010 Cheshire Parkway N, Suite 2
Plymouth, MN 55446 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Manufacturing Facility
Address: | 11400 73rd Avenue North
Maple Grove, MN 55369 |
| Primary Contact: | Sew-Wah Tay PhD
Libra Medical, Inc.
Tel: 612-801-6782
Fax: 763-477-6357
Email: swtay@libramed.com |
| Secondary Contacts: | Nicole Boser
Tel: (763) 488-2050
Fax: (763) 488-3441
Email: 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 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. |
| Intended Use: | 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, 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 to on vessels and
lymphatics up to and including 7 mm, and tissue bundles. |
| Technological
Characteristics: | The reprocessed vessel sealer has the same technological and performance
characteristics as the predicate, K130744. Similar to the predicate, this
reprocessed device seals vessels and lymphatics using radio frequency (RF)
energy to achieve its intended use and can mechanically divide the sealed areas
or tissue with a mechanical cutting device. The manner of reprocessing and
testing is identical to predicate K123096, Sterilmed reprocessed vessel sealer. |
| 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
validation (ISO 11135, USP ), 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 simulated use, visual
inspection, 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
• Push
Performance testing shows the reprocessed vessel sealers to perform as
originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed vessel sealer is safe, effective, and
substantially equivalent to the predicate device, Covidien LigaSure™ 5 mm,
Blunt Tip, Laparoscopic Sealer/Divider (K130744), as described in this
premarket notification submission. The reprocessing and validation methods
used are similar to the Sterilmed reprocessed vessel sealer predicate device
(K123096). |
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