(101 days)
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Not Found
No
The summary describes a system for delivering irrigation fluid and does not mention any AI or ML components or functionalities.
No
The device is used to deliver irrigation during surgical procedures, primarily to prevent overheating and clear the visual field, which are supportive functions for the surgical procedure itself rather than directly treating a disease or condition.
No
Explanation: The device is described as an irrigation system used during bipolar coagulation to prevent overheating, tissue adherence, and provide a clearer visual field. It facilitates a medical procedure rather than providing information for diagnosis.
No
The device description explicitly mentions a "Jet Irrigation Unit (GN090)" which is a hardware component responsible for delivering irrigation. The submission describes a system that includes hardware, not just software.
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, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Aesculap Jet Irrigation System is designed to deliver irrigation fluid directly to the tip of surgical forceps during a procedure. Its purpose is to prevent overheating, tissue adherence, and provide a clearer visual field during surgery.
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body. It is used on the body during a surgical procedure, not with samples taken from the body.
Therefore, the function and intended use of the Aesculap Jet Irrigation System clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Jet Irrigation System presented in this submission is designed for use with Aesculap's Bipolar Coagulator (GN060). The Jet Irrigation Unit (GN090) delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps (GK840R - GK847R). The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous "jet" irrigation provides a clearer visual field.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Jet Irrigation System presented in this submission is designed for use with Aesculap's Bipolar Coagulator (GN060). The Jet Irrigation Unit (GN090) delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps (GK840R - GK847R).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
JLAP
JUL 18 1997
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Aesculap Jet Irrigation System
April 7, 1997
| Submitted by: | Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080
Contact: Mary Ellen Holden
Phone: (415) 876-7000 x348
FAX: (415) 589-3007 |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Product: Aesculap Jet Irrigation System |
| | Common Name: Irrigation System |
Intended Use
The Jet Irrigation System presented in this submission is designed for use with Aesculap's Bipolar Coagulator (GN060). The Jet Irrigation Unit (GN090) delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps (GK840R - GK847R). The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous "jet" irrigation provides a clearer visual field.
Technological Characteristics
Aesculap's Jet Irrigation System is substantially equivalent to Codman's Malis Irrigation System in design features and technological characteristics.
Both the Jet Irrigation System and the Malis Irrigation System are designed to be used in conjunction with a Bipolar Coagulator. They provide delivery of precisely controlled irrigation to the tip of bipolar irrigation forceps.
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Performance Standards
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Jet Irrigation Unit complies with the requirements of Underwriters Laboratories, Inc., for medical and dental equipment.
In addition, the Bipolar Irrigation Forceps meet the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.)
The Jet Irrigation System will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.
Substantial Equivalence
Aesculap's Jet Irrigation System shares similar features and function with corresponding devices distributed by Aesculap and Codman.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Ellen Holden Regulatory Compliance Associate AESCULAP® . Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7030
JUL 18 1997
Re: K971310
Trade Name: Aesculap Jet Irrigation System Regulatory Class: II Product Code: GEI Dated: July 3, 1997 Received: July 7, 1997
Dear Ms. Holden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
3
action. In addition. FDA may publish further announcements concerning your device 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 device as described in your 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 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 device, 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 vours.
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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INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
大971310
Device Name: Aesculap Jet Irrigation System
Indication for Use:
Aesculap's Jet Irrigation System is designed for use with Aesculap's Bipolar Coagulator. The Jet Irrigation System delivers either precisely measured drip irrigation or a continuous jet stream of irrigation to the tip of Aesculap's Bipolar Irrigation Forceps. The use of drip irrigation serves to prevent overheating and tissue adherence during bipolar coagulation. Continuous "jet" irrigation provides a clearer visual field.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | R971310 |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | ----------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)