(80 days)
Not Found
Not Found
No
The provided text describes a traditional ultrasonic surgical instrument and does not mention any AI or ML components or functionalities.
Yes
The device is used for cutting and coagulating soft tissue incisions to control bleeding and minimize thermal injury during various surgical procedures. These are therapeutic interventions aimed at treating a patient's condition.
No
The device is described as a surgical instrument for cutting and coagulating soft tissue, not for diagnosis.
No
The device description explicitly states that the system has three essential parts: the generator/footswitch, the hand piece, and the instruments. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The description and intended use clearly state that the Harmonic Scalpel is a surgical instrument used for cutting and coagulating soft tissue during surgical procedures. It is applied directly to the patient's tissue.
- No Specimen Examination: There is no mention of examining specimens derived from the human body in vitro. The device operates directly on the patient's body.
Therefore, the Harmonic Scalpel falls under the category of a surgical instrument used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Harmonic Scalpel Shears Instruments are 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, plastic, pediatric, gynecologic, urologic and other open and endoscopic procedures.
The Harmonic Scalpel 5 mm Instruments with Protective Sleeve 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, plastic, gynecologic, 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).
The Harmonic Scalpel 10cm Sharp Curved Blade instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, and thoracic surgery.
The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 5 mm Instruments are 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, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
Product codes
LFL
Device Description
The Harmonic Scalpel Blades and Shears are ultrasonic surgical instruments for the cutting and coagulation of soft tissue incisions when bleeding control and minimal thermal injury are desired. The device system has three essential parts: the generator/ footswitch, the hand piece and the instruments, which are available in various lengths shapes and types. The selection of the appropriate instrument is a matter of surgeon preference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, soft palate, oral structures, oropharyngeal airway, Internal Mammary Artery (IMA)
Indicated Patient Age Range
pediatric, Not Found (for other indications)
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)
A clinical literature search was performed to show the use of the devices in plastic surgery.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
UltraCision Harmonic Scalpel Blades and Shears
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary
Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242
-
Contact Elizabeth Miller Regulatory Affairs Associate II Telephone: (513) 337-7146 Fax: (513) 337-1444 Email: Imiller12@eesus.jnj.com
Date Prepared October 28 , 2005 -
Trade Name: Harmonic Scalpel Blades and Shears Device Name Common or Usual Name: Instrument, Ultrasonic Surgical Classification Name: Electrosurgical Cutting and Coagulation Device [21 CFR 878.4400 (LFL)]
Predicate Device UltraCision Harmonic Scalpel Blades and Shears
Device Description The Harmonic Scalpel Blades and Shears are ultrasonic surgical instruments for the cutting and coagulation of soft tissue incisions when bleeding control and minimal thermal injury are desired. The device system has three essential parts: the generator/ footswitch, the hand piece and the instruments, which are available in various lengths shapes and types. The selection of the appropriate instrument is a matter of surgeon preference.
Indications for Use The Harmonic Scalpel Shears Instruments are 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, plastic, pediatric, gynecologic, urologic and other open and endoscopic procedures.
The Harmonic Scalpel 5 mm Instruments with Protective Sleeve 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, plastic, gynecologic, 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).
The Harmonic Scalpel 10cm Sharp Curved Blade instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general. plastic, gynecologic, and thoracic surgery.
The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
1
The Harmonic Scalpel 5 mm Instruments are 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, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
Technological Characteristics The Harmonic Scalpel Blades and Shears technological characteristics are the same as the predicate device. No changes (materials construction, specifications, manufacturing or sterilization processes) to the currently marketed device. The device differs only in the indications.
Performance Data A clinical literature search was performed to show the use of the devices in plastic surgery.
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC." The symbol in the center appears to be a stylized representation of a human figure or a caduceus-like design, consisting of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2006
Ms. Elizabeth Miller Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K053056
Trade/Device Name: Harmonic Scalpel Blades and Shears Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Il Product Code: LFL Dated: October 28, 2005 Received: October 31, 2005
Dear Ms. Miller:
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. Miller
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Barbara Buehrs
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Harmonic Scalpel Blades and Shears
Indications for Use:
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The Harmonic Scalpel 5 mm Instruments with Protective Sleeve is indicated for soft tissue incisions when I he farmont beatler of thin instruments will in the instruments can be used as an adjunct to or bleeding control and infinitial thermal injury are deels in general, plastic, gynecologic, ENT (Ears, Nose, Subsuitie for circulosurery, fusors, and boor responsible grand oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 10cm Sharp Curved Blade instruments are indicated for soft tissue incisions when I he flamone beatlyer toon bharp our rour are desired. The instrument can be used as an adjunct to or breeding control and inmind thermal mark a scalpels in general, plastic, gynecologic, and thoracic surgery.
The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to The I all the bleeding control and minimal thermal injury are desired. The instrument can be used a an be used when overalling only of and steel scalpels in general, plastic, gynecologic, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 5 mm Instruments are indicated for soft tissue incisions when bleeding control and I he frammome Dealped 3 mill risk antersonents can be used as an adjunct to or substitute for mintmal mermal may a beel scalpels in general, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
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)
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices
(Posted November 13, 2003)
| 510(k) Number | K053056 |
|---|---|
| --------------- | --------- |