(81 days)
Not Found
Not Found
No
The summary describes a traditional ultrasonic surgical device and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "surgical blade" used to "cut and coagulate soft bodily tissues and structures." It is indicated for various surgical procedures, including general, gynecological, ENT, and thoracic surgery. This aligns with the definition of a therapeutic device, as it is used to treat or alleviate disease, injury, or other medical conditions.
No
The device is described as a surgical blade used to cut and coagulate tissues, indicating it is a therapeutic device for performing surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is an "ultrasonically activated surgical blade with a protective sleeve," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the UltraCision Harmonic Scalpel is a surgical instrument used for cutting and coagulating soft bodily tissues during surgical procedures. This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with IVD devices.
Therefore, the UltraCision Harmonic Scalpel is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The UltraCision Harmonic Scalpel is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, gynecological ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures and oropharyngeal airway, and thoracic surgery including mobilization of the Internal Mammary Artcry (IMA).
Product codes
LFL
Device Description
The UltraCision Harmonic Scalpel is an ultrasonically activated surgical blade with a protective sleeve. These instruments are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft bodily tissues and structures, soft palate, oral structures, oropharyngeal airway, Internal Mammary Artery (IMA).
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
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Summary of Performance Studies
All previously submitted bench testing and animal studies demonstrated satisfactory performance in cutting and coagulation. The clinical information demonstrated satisfactory performance for the expanded indication.
Key Metrics
Not Found
Predicate Device(s)
UltraCision® Harmonic Scalpel® Blades with Protective Sleeve
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for Ethicon Endo-Surgery, Inc. The logo consists of a circular graphic on the left, followed by the company name in a simple, sans-serif font. Below the company name, it says "a Johnson & Johnson company" in a cursive font.
K 012176
4545 CREEK ROAD
CINCINNATI, OH 45242-2839
OCT - 1 2001
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY: Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
CONTACT: Ruth Ann Wood Senior Regulatory Affairs Associate Telephone: 513/337-3468 FAX: 513/337-1444
DATE PREPARED: July 11, 2001
NAME OF THE DEVICE: UltraCision® Harmonic Scalpel® Blades with Protective Sleeve Classification LFL
PREDICATE DEVICE: UltraCision® Harmonic Scalpel® Blades with Protective Sleeve
DEVICE DESCRIPTION:
The UltraCision Harmonic Scalpel is an ultrasonically activated surgical blade with a protective sleeve. These instruments are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.
INTENDED USE/INDICATION FOR USE:
The UltraCision Harmonic Scalpel is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, gynecological ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures and oropharyngeal airway, and thoracic surgery including mobilization of the Internal Mammary Artery (IMA).
1
TECHNOLOGICAL CHARACTERIZATION:
The UltraCision Harmonic Scalpel is a medical device that uses ultrasonic energy to cause mechanical vibrations to cut and coagulate soft tissues.
PERFORMANCE DATA:
All previously submitted bench testing and animal studies demonstrated satisfactory performance in cutting and coagulation. The clinical information demonstrated satisfactory performance for the expanded indication.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 2001
Ms. Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K012176
Trade/Device Name: UltraCision®Harmonic Scalpel® Blades with Protective Sleeve Regulation Number: 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: LFL Dated: July 11, 2001 Received: July 12, 2001
Dear Ms. Wood:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Ruth Ann Wood
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
510(k) NUMBER (IF KNOWN): K012176
DEVICE NAME: Ultra Cision Harmonic Scalpel Blades with Protective Sleeve
INDICATIONS FOR USE:
The Harmonic Scalpel is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpel in general, gynecologic, ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of Internal Mammary Artery (IMA).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANTOHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter-Use (Optional Format)
for Mark N Melberson
al, Restorative
510(k) Number K012176