(155 days)
The reprocessed cordless ultrasonic dissection devices are intended to be used for cutting soft tissue when control of bleeding and minimal thermal injury is desired. The devices can be used to coagulate isolated vessels up to 5 mm.
The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
The cordless ultrasonic dissection devices are intended to be used to position, grasp, seal and dissect soft tissues, as well as providing control for functions such as selecting power levels, and blade placement and position. The instruments are used with a reusable generator, reusable battery pack and include a torque wrench as an accessory piece (the torque wrench is designed to ensure that the generator is properly secured to the device). The instruments have a 5 mm shaft diameter, 14.5 mm active blade, dual-mode energy button and are available in a variety of lengths. They can be used to coagulate vessels up to 5 mm and are designed to be inserted and extracted through a compatible 5mm trocar when used endoscopically.
I am sorry, but the provided text is a 510(k) premarket notification for a reprocessed medical device, specifically a "Reprocessed Cordless Ultrasonic Dissection Device." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed clinical study with acceptance criteria for an AI/algorithm-based diagnostic device.
Therefore, the input text does not contain the information necessary to answer your request regarding acceptance criteria and a study proving a device meets those criteria for an AI/algorithm. Specifically, the document does not describe:
- Acceptance criteria for an AI/algorithm's performance.
- A study proving an AI/algorithm meets acceptance criteria.
- Sample size and data provenance for a test set of an AI/algorithm.
- Number and qualifications of experts for ground truth establishment for an AI/algorithm.
- Adjudication method for an AI/algorithm's test set.
- MRMC comparative effectiveness study for an AI/algorithm.
- Standalone performance study for an AI/algorithm.
- Type of ground truth used for an AI/algorithm.
- Sample size and ground truth establishment for the training set of an AI/algorithm.
The document describes non-clinical testing performed on the reprocessed physical device to ensure its functional performance, cleaning, sterilization, and biocompatibility are equivalent to new devices. This is a different type of evaluation altogether.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Sterilmed Incorporated Ms. Julie Bodmer Libra Medical 8401 73rd Ave North, Suite 63 Brooklyn Park, Minnesota 55448
Re: K143562
Trade/Device Name: Reprocessed Cordless Ultrasonic Dissection Device Regulatory Class: Unclassified Product Code: NLQ Dated: April 10, 2015 Received: April 14, 2015
Dear Ms. Bodmer:
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. Isting 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 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/Resourcesfor You/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 vours.
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 – Ms. Julie Bodmer
| Device Model | Shaft Rotation | Shaft Diameter | Shaft Length |
|---|---|---|---|
| SCD13 | 360° | 5 mm | 13 cm |
| SCD26 | 360° | 5 mm | 26 cm |
| SCD396 | 360° | 5 mm | 39 cm |
Reprocessed Single Use Device Models Included in Clearance:
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Indications for Use
510(k) Number (if known) K143562
Device Name
Reprocessed Cordless Ultrasonic Dissection Device
Indications for Use (Describe)
The reprocessed cordless ultrasonic dissection devices are intended to be used for cutting soft tissue when control of bleeding and minimal thermal injury is desired. The devices can be used to coagulate isolated vessels up to 5 mm.
The instruments can be used as an adjunct to or electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and other open and endoscopic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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6.0 510(K) SUMMARY
| Submitter andManufacturer: | Nicole BoserSterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446 |
|---|---|
| Manufacturing FacilityAddress: | 11400 73rd Avenue NorthMaple Grove, MN 55369 |
| Primary Contact: | Julie BodmerLibra Medical, Inc.Tel: 612-910-3412Fax: 763-477-6357Email: jbodmer@libramed.com |
| Secondary Contact: | Nicole BoserTel: (763) 488-3441Fax: (763) 488-2050Email: nboser@sterilmed.com |
| Date of Submission: | 15 December 2014 |
| Trade Name: | Reprocessed Cordless UltrasonicDissection Devices |
| Regulation Name: | Scalpel, Ultrasonic, Reprocessed |
| Device Classification: | Unclassified |
| Product Code: | NLQ |
| Predicate Devices: | Covidien SonicisionTM Cordless Ultrasonic Dissection Device, ModelSCD396 (K101797).Covidien SonicisionTM Cordless Ultrasonic Dissection Device, ModelsSCD13 and SCD26 (K141371). |
|---|---|
| DeviceDescription: | The cordless ultrasonic dissection devices are intended to be used toposition, grasp, seal and dissect soft tissues, as well as providing control forfunctions such as selecting power levels, and blade placement and position.The instruments are used with a reusable generator, reusable battery packand include a torque wrench as an accessory piece (the torque wrench isdesigned to ensure that the generator is properly secured to the device).The instruments have a 5 mm shaft diameter, 14.5 mm active blade, dual-mode energy button and are available in a variety of lengths. They can beused to coagulate vessels up to 5 mm and are designed to be inserted andextracted through a compatible 5mm trocar when used endoscopically. |
| Intended Use: | The reprocessed cordless ultrasonic dissection devices are intended to beused for cutting soft tissue when control of bleeding and minimal thermalinjury is desired. The devices can be used to coagulate isolated vessels upto 5 mm. |
| The instruments can be used as an adjunct to or substitute forelectrosurgery, lasers and steel scalpels in general, plastic, pediatric,gynecologic, urologic, exposure to orthopedic structures (such as spine andjoint space) and other open and endoscopic procedures. | |
| TechnologicalCharacteristics: | The reprocessed cordless ultrasonic dissection devices are identical intechnological and performance characteristics as the predicates, K101797and K141371. There are no differences in design, materials ofconstruction, and intended use. There are no changes to the clinicalapplications, patient population, performance specifications, or method ofoperation. |
| Functional andSafety Testing: | Representative samples of reprocessed cordless ultrasonic dissectiondevices were tested to demonstrate appropriate functional characteristics.Process validation testing was performed to validate the cleaning andsterilization procedures as well as device packaging. In addition, themanufacturing process includes visual and validated functional testing ofall products produced. |
| Summary ofNon-Clinical TestsConducted: | Specific non-clinical tests performed included: cleaning validation,sterilization verification, biocompatibility testing (ISO 10993-1), ethyleneoxide residual testing (ISO 10993-7), packaging validation (ASTM D4169), and shelf life validation (ASTM 1980). In addition, validation offunctional performance (bench testing) was performed through simulateduse, visual inspection, and fatigue testing. Testing performed:Vessel Seal Thermal Spread●Vessel Seal Burst (Static and Burst Pressure)●Device Functionality●Pad Functionality●Pad Retention●Tissue Sticking●Torque Wrench Functionality●Performance testing shows the reprocessed cordless ultrasonic dissectiondevices to perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed cordless ultrasonic dissectiondevices are safe, effective, and substantially equivalent to the predicatedevices, Covidien Sonicision™ Cordless Ultrasonic Dissection DeviceModel SCD396 (K101797) and Covidien Sonicision™ Cordless UltrasonicDissection Device Models SCD13 and SCD26 (K141371), as described inthis premarket notification submission. |
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