(115 days)
Not Found
No
The summary describes a reprocessed electrosurgical instrument and its functional characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used in surgical procedures for ligation and sealing of vasculature, lymphatics, and tissue bundles, which are therapeutic interventions.
No
The device, a vessel seamer, is described as an electrosurgical instrument used for sealing vessels, grasping tissue, and dissection during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is an electrosurgical instrument with physical components (shaft, tip, etc.) and is used with a hardware energy platform. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (general and gynecological, laparoscopic) to seal vessels, lymphatics, and tissue bundles. This is a direct surgical intervention on the patient's body.
- Device Description: The device is an electrosurgical instrument used with an energy platform for surgical procedures.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such in vitro examination of specimens.
The device is clearly intended for use during a surgical procedure on a living patient, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
Device Description
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.
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)
Functional and Safety Testing: Representative samples of reprocessed vessel sealers 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 ), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D.4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. 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.
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
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
、
| Predicate
Devices: | The reprocessed vessel sealers are substantially equivalent to the Covidien LigaSure™ Laparoscopic
Instruments (K092879 and K031011). |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | 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. |
| Intended Use: | The reprocessed vessel sealers are indicated for use in general and gynecological, laparoscopic surgical
procedures where ligation of vasculature is desired. The reprocessed vessel sealers can be used to seal vessels
up to and including 7 min, lymphatics, and tissue bundles. The reprocessed vessel sealers can also be used to
seal pulmonary vasculature when used with the ForceTriad™ energy platform. |
| Technological
Characteristics: | 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. |
| Functional and
Safety Testing: | Representative samples of reprocessed vessel sealers 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
), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D.4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980-07). In
addition, validation of functional performance (bench testing) was performed through simulated use, visual
inspection, fatigue testing, and function testing. Performance testing shows the reprocessed vessel sealers to
perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed vessel sealers are safe, effective, and substantially equivalent to the
predicate devices, Covidien LigaSure™ Laparoscopic Instruments (K092879 and K031011), as described in
this premarket notification submission. |
1
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
2
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
3
Image /page/3/Picture/0 description: The image shows the word "STERILMED" in a simple, sans-serif font. To the left of the word is a circular logo. The logo appears to have a horizontal line through the middle of the circle.
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