ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE

K971302 · Ethicon Endo-Surgery, Inc. · LFL · Jul 7, 1997 · SU

Device Facts

• Record ID: K971302
• Device Name: ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: LFL · SU
• Decision Date: Jul 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

UltraCision 5mm LaparoSonic Hook Blades and HS2 Blade are sterile, single-patient-use surgical instruments. System components include titanium blade with non-removable sheath, hand piece, blade adaptor, blade wrench, generator, foot switch, and cart. Device utilizes ultrasonic energy for cutting soft tissue and providing hemostasis. Operated by surgeons in general and thoracic surgical settings. Ultrasonic activation enables tissue incision and coagulation with minimal thermal injury compared to traditional electrosurgery or lasers. Output is mechanical ultrasonic vibration at the blade tip; healthcare providers use this to perform precise tissue dissection and vessel sealing, potentially reducing thermal damage to surrounding structures.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations demonstrated acceptable performance in cutting, blunt tissue dissection, and coagulation during the mobilization of the Internal Mammary Artery (IMA).

Technological Characteristics

Titanium blade with non-removable sheath. Ultrasonic energy activation. Working lengths: 32 cm (5mm Hook Blades) and 10 cm (HS2 Blade). System includes generator, hand piece, and foot switch. Sterile, single-patient-use.

Indications for Use

Indicated for soft tissue incisions in general and thoracic surgery, including Internal Mammary Artery (IMA) mobilization, when bleeding control and minimal thermal injury are desired. Adjunct or substitute for electrosurgery, lasers, and steel scalpels.

Submission Summary (Full Text)

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TEL:[phone] Jul 07 97 15:47 No.003 P.02
ETHICON ENDO-SURGERY, INC.
a Johnson & Johnson company
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

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TEL:[phone]
Jul 07 97 15:47 No.003 P.03

# 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 [phone]

FAX number [phone] |
| Date | April 4, 1997 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

Re: K971302
JUL - 7 1997
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, Drug, 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 II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug

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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 regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

## Statement

The following is the indication for Use Statement:

510(k) Number K_971302
Device Name UltraCision 5mm Hard Sheath LaparoSonic® Blade and UltraCision HS2 Blade

## 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).


Prescription Use ☑
(Per 21 CFR 801.109)