(105 days)
No
The device description focuses on mechanical surgical instruments (forceps, clamps, scissors, trocars) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated for "therapeutic general endoscopy and laparoscopy surgery" and facilitates "grasping, cutting, and manipulation of soft tissue and blood vessels", which are therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery."
No
The device description explicitly details physical components such as forceps, clamps, scissors, trocar sleeves, and trocar pins made of materials like Stainless Steel, Grilon, and PEEK. These are hardware components, not software.
Based on the provided text, the Aesculap AdTec® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- AdTec® Function: The description clearly states that AdTec® is used for "grasping, cutting, and manipulation of soft tissue and blood vessels during laparoscopic procedures." These are surgical tools used within the body, not for testing samples outside the body.
- Intended Use: The intended use is for "diagnostic and therapeutic general endoscopy and laparoscopy surgery," which involves direct intervention on the patient's body.
Therefore, the AdTec® device falls under the category of surgical instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Aesculap's AdTec® is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery.
Product codes
GCJ
Device Description
AdTec® is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery. The system consists of single-use and reusable forceps, clamps, and scissors made of Stainless Steel with monopolar or bipolar capabilities. They facilitate in the grasping, cutting, and manipulation of soft tissue and blood vessels during laparoscopic procedures. The single-use instruments come completely assembled in one single piece, and are available in various lengths ranging from 220mm - 420mm. The reusable instruments are modular and consist of a jaw insert and an insulated outer tube with interchangeable ratcheting and non-ratcheting handles. They are also available in lengths ranging from 220mm - 420mm. The system also includes a single use trocar sleeve and a reusable trocar pin. The trocar sleeve is made of Grilon, and the trocar pin is made of Stainless Steel and PEEK. The trocar sleeve and trocar pin are available in a 3.5mm diameter and a 70mm length. They are accessories for the 3.5mm trocars cleared under K123102.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric (3.5mm instruments only)
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
The modifications to the subject submission were evaluated using a failure mode and effects (FMEA) risk analysis and no new risks were identified.
The use of these devices in adults and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery does not effect the risk analysis included in the submission of the primary predicate (K123102).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Aesculap, Inc. Ms. Jessica Stigliano Regulatory Affairs Associate 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K160393 Trade/Device Name: AdTec Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 18, 2016 Received: March 21, 2016
Dear Ms. Jessica Stigliano:
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 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 of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160393
Device Name AdTec®
Indications for Use (Describe)
Aesculap's AdTec® is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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B. Special 510(k) Summarv (as required by 21 CFR 807.92)
AdTec® February 8, 2016
| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Jessica Stigliano
610-984-9063
610-791-6882 (fax)
jessica.stigliano@aesculap.com |
| COMMON NAME: | Laparoscope, General and Plastic Surgery |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| REGULATION NUMBER: | 876.1500 |
| PRODUCT CODE: | GCJ |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes the modified components of AdTec® are substantially equivalent to the components of the Aesculap Sovereign® mini System (K123102), Aesculap Endoscopic Instruments (K940936) and Aesculap Sovereign® Bipolar Instruments (K001330).
DEVICE DESCRIPTION
AdTec® is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery. The system consists of single-use and reusable forceps, clamps, and scissors made of Stainless Steel with monopolar or bipolar capabilities. They facilitate in the grasping, cutting, and manipulation of soft tissue and blood vessels during laparoscopic procedures. The single-use instruments come completely assembled in one single piece, and are available in various lengths ranging from 220mm - 420mm. The reusable instruments are modular and consist of a jaw insert and an insulated outer tube with interchangeable ratcheting and non-ratcheting handles. They are also available in lengths ranging from 220mm - 420mm. The system also includes a single use trocar sleeve and a reusable trocar pin. The trocar sleeve is made of Grilon, and the trocar pin is made of Stainless Steel and PEEK. The trocar sleeve and trocar pin are available in a 3.5mm diameter and a 70mm length. They are accessories for the 3.5mm trocars cleared under K123102.
INDICATIONS FOR USE
Aesculap's AdTec system is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery.
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TECHNOLOGICAL CHARACTERISTICS
As is established in this submission, Aesculap's AdTec is substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.
PERFORMANCE DATA
The modifications to the subject submission were evaluated using a failure mode and effects (FMEA) risk analysis and no new risks were identified.
The use of these devices in adults and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery does not effect the risk analysis included in the submission of the primary predicate (K123102).
PRIMARY PREDICATE
- Aesculap Sovereign® mini System (K123102) ●
REFERENCE DEVICES
CONCULSION
Aesculap believes that the instruments presented in this submission are substantially equivalent in design, material, and indications for use to Aesculap's currently marketed devices presented in the revised 510(k) summary.