(76 days)
Not Found
No
The description focuses on the mechanical and ultrasonic functions of the device, with no mention of AI or ML capabilities.
No
The device is described as an instrument for cutting and coagulating tissue during surgery, not for treating or preventing a disease or condition.
No
The device is described as an instrument for cutting and coagulating tissue (soft tissue incisions, vessel cutting and coagulation), which is a treatment function, not a diagnostic one. Its "Intended Use / Indications for Use" focuses on surgical intervention rather than identifying a medical condition.
No
The device description clearly describes a physical surgical instrument with a handle, buttons, blade, and clamp arm, which are hardware components. It also mentions operating with a generator and hand piece, further indicating a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue incisions" and is used in surgical procedures on the human body. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a surgical instrument with a handle, buttons, blades, and a clamp arm, designed for cutting and coagulating tissue and vessels. This is consistent with a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device 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 and other open procedures.
Product codes
NLQ
Device Description
The Ultrasonic Curved Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The instrument has a working length of 9cm, an active blade length of 16mm, and utilizes a curved blade and clamp arm. The Ultrasonic Curved Shears device allows for the cutting and coagulation of vessels up to and including 5mm in diameter. The Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are designed to operate with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Blue Hand Piece (HPBLUE).
Note: Only the Ultrasonic Curved Shears with torque wrench and grip assist is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.
The design, materials, and intended use of Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are identical to the predicate device. The mechanism of action of Ultrasonic Curved Shears with torque wrench and grip assist is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition. Ascent Healthcare Solutions' reprocessing of Ultrasonic Curved Shears with torque wrench and grip assist includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Curved Shear with torque wrench and grip assist is tested for appropriate function of its components prior to packaging and labeling operations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Curved Shears. This included the following tests: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation. Performance testing demonstrates that Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K 100 537
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Page 1 of 2
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | MAY 12 2010 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Contact: | Ramona Kulik
Regulatory Affairs Engineer
480.763.5300 (o)
480.763.2952 (f)
rkulik@ascenths.com | |
| Date of preparation: | February 24, 2009 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Ultrasonic Curved
Shears with torque wrench and grip assist | |
| | Classification Name: Scalpel, Ultrasonic, Reprocessed | |
| Predicate Device
K063192 | 510(k) Title
Harmonic Focus Curved Shears and
Torque Wrench | Manufacturer
Ethicon Endo-Surgery,
Inc. |
| Device description: | The Ultrasonic Curved Shears is an instrument consisting of a
scissor handle housing assembly with hand control buttons (MIN
for minimum power level and MAX for maximum power level).
The instrument has a working length of 9cm, an active blade
length of 16mm, and utilizes a curved blade and clamp arm. The
Ultrasonic Curved Shears device allows for the cutting and
coagulation of vessels up to and including 5mm in diameter. | |
| | The Reprocessed Ultrasonic Curved Shears with torque wrench
and grip assist are designed to operate with the Harmonic™
Generator 300 (GEN04) and Harmonic™ Blue Hand Piece
(HPBLUE). | |
| | Note: Only the Ultrasonic Curved Shears with torque wrench
and grip assist is the subject of this submission, the reusable
hand piece, generator, and any other related equipment are not
included in the scope of this submission. | |
| Indications for Use: | The Reprocessed Ultrasonic Curved Shears is indicated for soft
tissue incisions when bleeding control and minimal thermal
injury is desired. The device 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 and other open procedures. | |
1
K1 00 537
Page 2 of (2)
Technological characteristics:
The design, materials, and intended use of Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are identical to the predicate device. The mechanism of action of Ultrasonic Curved Shears with torque wrench and grip assist is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition. Ascent Healthcare Solutions' reprocessing of Ultrasonic Curved Shears with torque wrench and grip assist includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Curved Shear with torque wrench and grip assist is tested for appropriate function of its components prior to packaging and labeling operations.
Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Curved Shears. This included the following tests:
- Biocompatibility �
- Validation of reprocessing .
- Sterilization Validation ●
- Function test(s) �
- Packaging Validation .
Performance testing demonstrates that Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist perform as originally intended.
Conclusion:
Ascent Healthcare Solutions concludes that the Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are safe, effective, and substantially equivalent to the predicate device as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 2 2010
Ascent Healthcare Solutions % Ms. Ramona Kulik Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044
Re: K100537
Trade/Device Name: Reprocessed Ultrasonic Curved Shears with Torque Wrench And Grip Assist
Regulatory Class: Unclassified Product Code: NLQ Dated: February 24, 2010 Received: February 25, 2010
Dear Ms. Kulik:
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
3
Page 2 - Ms. Ramona Kulik
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.
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/ucm115809.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 A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
K100 537 510(k) Number (if known):
Device Name: Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist
Indications For Use:
The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device 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 and other open procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Detkrogh for max
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100537
5
| Reprocessor | Model Number | Description |
|---|---|---|
| Ascent Healthcare Solutions | FCS9 | Reprocessed Ultrasonic Curved |
| Shears (9cm long/16mm blade | ||
| length) with | ||
| TWBLUE | Torque wrench | |
| GABLUE | Grip Assist |
Image /page/5/Picture/1 description: The image shows a Harmonic Focus scalpel. The scalpel is white and has a black handle. The scalpel is lying on a table. The scalpel has the words "Harmonic Focus" printed on the side.
Figure 1 Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist
Neil R. Ode for man
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100537