(90 days)
Not Found
Not Found
No
The description focuses on the mechanical and ultrasonic properties of the surgical blades and system components, with no mention of AI or ML.
Yes
The device is used for soft tissue incisions and dissection, which are therapeutic interventions aimed at treating or managing a medical condition.
No
This device is used for surgical incisions and tissue dissection, specifically mentioned for cutting, blunt tissue dissection, and coagulation, rather than for identifying or diagnosing a condition.
No
The device description explicitly details physical components such as titanium blades, sheaths, hand pieces, generators, and a cart, indicating it is a hardware-based medical device.
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" and is used in "general and thoracic surgery". This describes a surgical instrument used directly on a patient's body for treatment or diagnosis in vivo.
- Device Description: The description details a surgical blade and associated equipment used for cutting and coagulation of tissue. This is consistent with a surgical device, not a device used to examine specimens in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, this device falls under the category of a surgical instrument used for direct patient intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UltraCision 5mm LaparoSonic® Hook Blades and UltraCision HS2 Blade 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 and thoracic surgery, including the mobilization of the Internal Mammary Artery (IMA).
Product codes
LFL
Device Description
The UltraCision 5mm LaparoSonic® Hook Blade instruments are two styles of sterile, single patient use instruments consisting of a titanium blade with a non-removable sheath. The two styles consist of a Sharp Hook and Dissecting Hook. The working lengths are approximately 32 cm.
The UltraCision HS2 Blade is a sharp hook and has a working length of approximately 10 cm. The system consists of a blade affixed with a sheath, a hand piece, blade adaptor, blade wrench, generator, foot switch and cart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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
Not Found
Summary of Performance Studies
Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in cutting, blunt tissue dissection and coagulation in the mobilization of the IMA.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/3 description: The image shows a logo with a circular design on the left and text on the right. The circular design features curved lines that resemble a hand or a plant. To the right of the logo, the word "ETHIC" is written in block letters. Below "ETHIC", the name "Johnson" is written in cursive.
ETHICON ENDO-SURGERY, INC. on John ron company
- A.C.L.O.S.A.N.
A.C.L.O.S.A.N. - 45242285
K 971302 JUL - 7 1997
510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under the
Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is
summarized below For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule "...510(k) Summaries and
510(k) Statements..." (21 CFR § 807) and can be used to provide a substantial
equivalence summary to anyone requesting it from the Agency. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The UltraCision 5mm LaparoSonic® Hook Blade instruments are two styles
of sterile, single patient use instruments consisting of a titanium blade with a
non-removable sheath. The two styles consist of a Sharp Hook and Dissecting
Hook. The working lengths are approximately 32 cm.
The UltraCision HS2 Blade is a sharp hook and has a working length of
approximately 10 cm. The system consists of a blade affixed with a sheath, a
hand piece, blade adaptor, blade wrench, generator, foot switch and cart. |
| Intended use | The intended use for the New Device is the same as that of the Predicate
Device in that it is intended for cutting soft tissue and providing hemostasis in
general and thoracic surgery. |
| Indications
statement | The UltraCision 5mm LaparoSonic® Hook Blades and UltraCision HS2 Blade
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 and thoracic surgery, including the
mobilization of the Internal Mammary Artery (IMA). |
Continued on next page
1
- 전 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
510(k) Summary of Safety and Effectiveness, Continued
| Technological
characteristics | The technological characteristics of the New Devices are the same as the
Predicate Device. The same ultrasonic characteristics remain as a method of
activation |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
data | Pre-clinical laboratory evaluations were performed to ensure that the device
can be used as designed. The studies demonstrated acceptable performance in
cutting, blunt tissue dissection and coagulation in the mobilization of the IMA. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and
the information provided herein, we conclude that the New Devices are
substantially equivalent to the Predicate Device under the Federal Food,
Drug and Cosmetic Act. |
| Contact | Lonnie Pace
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242
Work phone (513) 786-7141
FAX number (513)786-7134 |
| Date | April 4, 1997 |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three flowing lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lonnie Pace Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
JUL - 7 1997
Re: K971302 UltraCision™ 5mm Hard Sheath LaparoSonic® Hook Blades and UltraCision™ HS2 Blade Regulatory Class: Unclassified Product Code: LFL Dated: April 4, 1997 Received: April 8, 1997
Dear Mr. Pace:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class Il (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug
3
Page 2 - Mr. Lonnie Pace
Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celía M. Witten Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use Statement
Statement
The following is the indication for Use Statement:
510(k) Number K_971302 Device Name UltraCision Smm Hard Sheath LaparoSonic® Bladc.and ... . ....... UltraCision HS2 Blade
Indications for Usc
The UltraCision Smm LaparoSonic® Hook Blades and UltraCision HS2 Blade 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 and thoracic surgery, including the mobilization of the Internal Mammary Artery (IMA).
(! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Off Divisio reral Restorative Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109)