(30 days)
Not Found
No
The description focuses on the mechanical aspects and materials of the trocar system, with no mention of AI or ML capabilities.
No
Explanation: The device is an endoscopic instrument used for puncture and port establishment in laparoscopic surgery, which is a surgical tool, not a therapeutic device designed to treat a condition.
No
Explanation: The device is described as an endoscopic instrument for creating a port of entry into the abdominal cavity for other endoscopic instruments. Its function is to facilitate access during surgery, not to diagnose a condition.
No
The device description clearly states that the device is a "Hybrid Trocar System" made from biocompatible materials and available in various physical sizes and configurations (diameter, length, with/without stopcock, threaded/smooth). This indicates a physical medical device, not a software-only one.
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 "puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments" in surgical procedures (laparoscopy). This is a surgical tool used directly on the patient's body.
- Device Description: The description details a physical instrument (trocar) used for creating access points during surgery.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVDs are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical instrument used for access during a procedure.
N/A
Intended Use / Indications for Use
The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.
Product codes
FBQ, GCJ
Device Description
Aesculap's Hybrid Trocar System can be used in laparoscopic general surgery. gynecology, and urology. The trocars are made from biocompatible materials. They are available as reusable in 3.5, 5, 10 or 12mm diameter with lengths of 60, 110, and 150mm. The trocars are offered with or without a stopcock, and threaded or smooth. The devices are color coded for easy identification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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
No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
K101937
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Hybrid Trocar Svstem July 6, 2010
COMPANY:
1
ﺧ
AUG 1 1 2010
Aesculap®, Inc. 3773 Corporate Parkway Center Vallev, PA 18034 Establishment Registration Number: 2916714
CONTACT: Denise R. Adams 800-258-1946 ext. 5076 (phone) 610-791-6882 (fax) Denise. Adams @ aesculap.com
COMMON NAME: Trocar
CLASSIFICATION NAME: Trocar
REGULATION NUMBER: 876.5090
PRODUCT CODE: FBQ
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the modified trocars and accessories are substantially equivalent to the existing components of the Aesculap Trocar Instrument Set (Interchangeable) (K942053) and Aesculap Needlescopic Instrument System (K982623) and VECTEC's Disposable Trocars (K071976).
DEVICE DESCRIPTION
Aesculap's Hybrid Trocar System can be used in laparoscopic general surgery. gynecology, and urology. The trocars are made from biocompatible materials. They are available as reusable in 3.5, 5, 10 or 12mm diameter with lengths of 60, 110, and 150mm. The trocars are offered with or without a stopcock, and threaded or smooth. The devices are color coded for easy identification.
INDICATIONS FOR USE
The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.
TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)}
The new trocars in the Hybrid Trocar System are offered in similar shapes and sizes as the predicate devices. All the components are manufactured from Stainless Steel and PEEK for the reusable and Polycarbonate for the disposable.
1
SPECIAL 510(k) Premarket Notification
公
K101937
Page 2 of 2
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 Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2000 1 1 2010
Aesculap®, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K101937
Trade/Device Name: Aesculap Hybrid Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 06, 2010 Received: July 12, 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 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/CDRHQffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
AUG 1 1 2010
510(k) Number:_
Device Name: Aesculap Hybrid Trocars
Indications for Use:
The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.
Prescription Use ____________________________ and/or Over-the-Counter 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)
Neil R. Oslen for mka
Division Sign $80
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101937