(93 days)
No
The description focuses on the mechanical and ultrasonic functions of the device, with no mention of AI or ML capabilities.
Yes
The device is indicated for soft tissue incisions with bleeding control and minimal thermal injury, providing therapeutic effects like cutting and coagulation.
No
Explanation: The device is indicated for soft tissue incisions, cutting, and coagulation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines a physical instrument with a handle, buttons, shaft, blade, and clamp arm, designed to be used in surgical procedures. It also mentions operating with a generator and handpiece, indicating hardware components.
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 when bleeding control and minimal thermal injury are desired." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument with a handle, shaft, blade, and clamp arm, designed for cutting and coagulating tissue and vessels. This is consistent with a surgical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue biopsies) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed to be used in vitro (in glass, or outside the living organism) to examine specimens from the human body. This device is used in vivo (in the living organism) during surgery.
N/A
Intended Use / Indications for Use
The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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 Coagulating 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). An audible and tactile mechanism is integrated into the handle housing to indicate full closure. The Ultrasonic Coagulating Shears is 18 cm long, shaft diameter of 8.5 mm, with an active blade length of 18 mm. The blade and clamp arm are straight allowing them to function through an incision without the use of a trocar. The Ultrasonic Coagulating Shears allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. The Ultrasonic Coagulating Shears is designed to operate with the Harmonic TM Generator 300 (GEN04) and the Hand Piece (HP054).
Note: Only the Ultrasonic Coagulating Shears 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 Technological Ultrasonic Coagulating Shears are identical to the predicate characteristics: device. The mechanism of action of Ultrasonic Coagulating Shears 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 Coagulating Shears includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Coaqulating Shear 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Coaqulating Shears. This included the following tests:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation
Performance testing demonstrates that Reprocessed Ultrasonic Coagulating Shears perform as originally intended.
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
N/A
0
Page 1 of 2
MAR - 4 2010 K093709 SECTION 5: 510(k) SUMMARY
ﺎ ﻳﺎﺭ ﺍﻟﻌ
:
・・
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Contact: | Moira Barton-Varty
Senior Director Regulatory Affairs
480.763.5300 (o)
480.763.5350 (f)
mbarton@ascenths.com | |
| Date of preparation: | November 30, 2009 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Ultrasonic Coagulating
Shears
Classification Name: Scalpel, Ultrasonic, Reprocessed | |
| Predicate Device
K062000 | 510(k) Title
Harmonic Wave Coagulating Shears
With Scissor Handle and Hand
Control, Model Wave18S; Harmonic
Disposable Torque Wrench | Manufacturer
Ethicon Endo-Surgery,
Inc. |
| Device description: | The Ultrasonic Coagulating 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). An audible and tactile mechanism is integrated into the
handle housing to indicate full closure. The Ultrasonic
Coagulating Shears is 18 cm long, shaft diameter of 8.5 mm,
with an active blade length of 18 mm. The blade and clamp arm
are straight allowing them to function through an incision without
the use of a trocar. The Ultrasonic Coagulating Shears allows
for the cutting and coagulation of vessels up to and including 5
mm in diameter. | |
| | The Ultrasonic Coagulating Shears is designed to operate with
the Harmonic TM Generator 300 (GEN04) and the Hand Piece
(HP054). | |
| | Note: Only the Ultrasonic Coagulating Shears 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.
other related equipment are not included in the scope of this
1
093702
ﮩ
Page 2 of ②
Indications for Use: The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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.
The design, materials, and intended use of Reprocessed Technological Ultrasonic Coagulating Shears are identical to the predicate characteristics: device. The mechanism of action of Ultrasonic Coagulating Shears 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 Coagulating Shears includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Coaqulating Shear 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 Coaqulating Shears. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- . Sterilization Validation
- Function test(s) ●
- Packaging Validation .
Performance testing demonstrates that Reprocessed Ultrasonic Coagulating Shears perform as originally intended.
Ascent Healthcare Solutions concludes that the modified Conclusion: devices (Reprocessed Ultrasonic Coagulating Shears) 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR - 4 2010
Ascent Healthcare Solutions % Ms. Moira Barton-Varty Senior Director of Regulatory Affairs 10232 South 51st Street Phoenix, Arizona 85044
Re: K093702
Trade/Device Name: Reprocessed Ultrasonic Coagulating Shears Regulatory Class: Unclassified Product Code: NLQ Dated: February 23, 2010 Received: February 24, 2010
Dear Ms. Barton-Varty:
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
3
Page 2 - Mr.
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/ReportalProblem/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 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
93702 510(k) Number (if known):
Device Name: Reprocessed Ultrasonic Coagulating Shears
Indications For Use:
The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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 × (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)
Neil RP Ogilvie for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093702
Page 12
5
| Reprocessor | Model Number | Description |
|---|---|---|
| Ascent Healthcare Solutions | Wave18S | Reprocessed Ultrasonic |
| Coagulating Shears |
Scissor Handle with Hand
Control |
| | | 8.5 mm diameter / 18 cm long |
Image /page/5/Picture/1 description: The image shows a medical device, specifically a Harmonic scalpel. The device has a long, thin shaft with a grasping mechanism at the end. The handle is white and has the words "I-harmonic wave" printed on it.
Figure 1 Reprocessed Ultrasonic Coagulating Shears
YhilRP Oglin for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093702