(16 days)
Not Found
No
The device description focuses on mechanical instruments for applying surgical clips and does not mention any software, data processing, or AI/ML components.
No
This device is a surgical instrument (clip applier) used for ligating and marking vessels and tubular structures, not for treating a disease or condition in itself.
No
The device is used for ligating and marking vessels and tubular structures during surgery, which is a therapeutic or operational function, not a diagnostic one.
No
The device description clearly states it is a reusable stainless steel instrument (hardware) used in surgery.
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 devices are for "ligating and marking vessels and tubular structures whenever a ligating clip is used/indicated" in endoscopic and/or open surgery. This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details reusable stainless steel instruments (clip appliers) used to apply clips. This is a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used during a procedure.
N/A
Intended Use / Indications for Use
The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures wherever a ligating clip is used/indicated.
Product codes (comma separated list FDA assigned to the subject device)
FZP/DSS
Device Description
Aesculap's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in either laparoscopic or open surgery. The laparoscopic appliers are available in either a 10 or 12mm diameter with a length of 310mm. The Clip Appliers are a nonmodular, one-piece, design for single fire use.
The Open Surgery Appliers are available in lengths of 150mm (small) to 280mm (Xlarge) with jaw angles of 25, 65, and 90 degrees. The handles of the open surgery appliers will be color coded for easy identification of the matching clip size.
Both types of appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge hold either 8, 6, or 2 clips per cartridge based on the size of the clip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels and tubular structures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
KC80753 Page 1/2
Endoscopic Clip System
Page 1 of 2
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Endoscopic Clip System March 17, 2008
APR - 2 2008 COMPANY: Aesculap®, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
- CONTACT: Lisa M. Boyle 800-258-1946 (phone) 610-791-6882 (fax) lisa.boyle@aesculap.com (email)
- COMMON NAME: Endoscopic Clips and Appliers
CLASSIFICATION NAME: Clips, Implantable
REGULATION NUMBER: 878.4300/870.3250
PRODUCT CODE: FZP/DSS
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Endoscopic Clips and Applier modifications are substantially equivalent to the existing components of the Aesculap Endoscopic Clip Appliers (K962493).
DEVICE DESCRIPTION
Aesculap's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in either laparoscopic or open surgery. The laparoscopic appliers are available in either a 10 or 12mm diameter with a length of 310mm. The Clip Appliers are a nonmodular, one-piece, design for single fire use.
The Open Surgery Appliers are available in lengths of 150mm (small) to 280mm (Xlarge) with jaw angles of 25, 65, and 90 degrees. The handles of the open surgery appliers will be color coded for easy identification of the matching clip size.
Both types of appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge hold either 8, 6, or 2 clips per cartridge based on the size of the clip.
INDICATIONS FOR USE
The devices presented in this submission are intended for use in endoscopic and/or open surgery for ligating and marking vessels and tubular structures wherever a ligating clip is used/indicated.
1
K080753 page2/2
Endoscopic Clip System
Page 2 of 2
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
The new clip appliers and clips of the Endoscopic Clip System are offered in similar in shapes and sizes as the predicate device. All the components are manufactured from Stainless Steel / Titanium, which is the same material as the predicate devices.
PERFORMANCE DATA
No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2008
Aesculap, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K080753
Trade/Device Name: Aesculap Endoscopic Clip Appliers with Disposable Clip Magazine Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: March 17, 2008 Received: March 17, 2008
Dear Ms. Boyle:
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. Lisa M. Boyle
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Melleman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number: K060753
Device Name: Aesculap Endoscopic Clip Appliers with Disposable Clip Magazine
Indications for Use:
The devices presented in this submission are intended for use in endoscopic and open surgery for ligating and marking vessels and tubular structures whenever ligating clips are used/poir oand
X _____ and/or Over-the-Counter Use _ Prescription Use (Part 21 CFR 801 Subpart D) (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)
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Division of General, Restorative, and Neurological Devices
510(k) Number K080753