(11 days)
Not Found
No
The description focuses on the mechanical function of a clip applier and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an instrument for ligating and marking vessels and tubular structures during surgery, which is a surgical tool, not a therapeutic device. It is used with ligating clips to close off structures, which is a mechanical action, not a therapy.
No
Explanation: The device, Aescular's Clip Appliers, is described as an instrument for ligating and marking vessels and tubular structures during surgery, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to identify or analyze a medical condition.
No
The device description explicitly states it is a reusable stainless steel instrument, which is a hardware component.
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 "ligating and marking vessels and tubular structures whenever ligating clips are used/indicated" in endoscopic and/or open surgery. This describes a surgical instrument used directly on the patient's body.
- Device Description: The description details a reusable stainless steel instrument used for applying clips during surgery. This aligns with a surgical tool, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and surgical.
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 whenever ligating clips are used/indicated.
Product codes
FZP/DSS
Device Description
Aescular's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in laparoscopic surgery. The clip appliers are available in 12mm diameter with a length of 330mm. The clip appliers are a non-modular, one-piece design for single fire use. These appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge holds 4 clips.
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 performarce 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KIO2081
SPECIAL 510(k) Premarket Notification
Endoscopic Clip System- Line Extension
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B. Endoscopic Clip System July 23, 2010 AUG - 6 2010 Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Vallev, PA 18034 Establishment Registration Number: 2916714 Denise R. Adams CONTACT: 800-258-1946 (phone) 610-791-6882 (fax) denise.adams@aesculap.com (email) COMMON NAME: Endoscopic Clips and Appliers CLASSIFICATION NAN.E: Clips, Implantable REGULATION NUMBER: 878.4300/870.3250 PRODUCT CODE: FZP/DSS
SUBSTANTIAL EQUIVALENCE
Aesculabo, Inc. believes that the Endoscopic Clips and Applier modifications are substantially equivalent to the existing components of the Aesculap Endoscopic Appliers and Double Ligating Clips (K080753).
DEVICE DESCRIPTION
Aescular's Clip Appliers are reusable stainless steel instruments. The clip appliers can be used in laparoscopic surgery. The clip appliers are available in 12mm diameter with a length of 330mm. The clip appliers are a non-modular, one-piece design for single fire use. These appliers are designed for use with a disposable clip magazine. The new clip magazine cartridge holds 4 clips.
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 whenever ligating clips are used/indicated.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The new clip appliers and clips of the Endoscopic Clip System are offered in similar 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.
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Page 2 of 2
PERFORMANCE DATA
No applicable performarce standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap®, Inc. % Ms. Denise R. Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
AUG - 6 2010
Re: K102081
Trade/Device Name: Aesculap Endoscopic Clip Appliers with Disposable Clip Magazine Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: July 23, 2010 Received: July 26, 2010
Dear Ms. Adams:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Denise R. Adams
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1102081
Indications for Use
AUG - 6 2010
K102081 510(k) Number (if known):
Device Name: 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/or open surgery for ligating and marking vessels and tubular structures whenever ligating clips are used/indicated.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dainl Kree fan MKM
(Division Sign Off)
Division of Surgical, Onhopedic, and Restorative Devices
Page 1 of
510(k) Number K102081
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