(60 days)
Not Found
No
The device description and performance studies focus on mechanical irrigation and suction functions, manually controlled by the surgeon. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes.
The device is used for irrigation and suctioning during laparoscopic surgery to remove fluids, blood, and tissue debris, and to maintain a clear view of the surgical site, which are considered therapeutic actions in a surgical context.
No
The device is used for irrigation and suctioning during laparoscopic surgery to maintain a clear view of the surgical site, not to diagnose a condition.
No
The device description explicitly details physical components like a control handpiece, tubing set, and cannulae, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for irrigation and suctioning during laparoscopic surgical procedures to clear the surgical field. This is a direct intervention on the patient during surgery, not an in vitro test performed on a sample taken from the body.
- Device Description: The description details a system for delivering fluids and applying suction within the body during surgery. It involves cannulae inserted into the surgical site.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, using reagents, or providing diagnostic information based on the analysis of biological samples.
The device is a surgical tool used for maintaining visibility and managing fluids within the surgical field during laparoscopic procedures.
N/A
Intended Use / Indications for Use
ab medica Irrigation/Suction Gravity System is indicated for use in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
ab medica Irrigation/Suction Gravity System is intended for irrigation and suctioning of the surgical field during laparoscopic surgery. This device is intended to be used in the operating room and by surgeons only.
The system consists of control handpiece pre-connected to a tubing set and removable cannula. The tubing set and the 5 mm and 10 mm cannulae are single-use devices and provided in sterile condition. Only the 3 mm reusable cannula is provided non sterile. The system is used during laparoscopic surgery to deliver sterile irrigation fluids and/or to produce suction to evacuate blood and small tissue debris, and t o maintain a clear view of the surgical site. Irrigation and suctioning functions are provided through the cannula, which is inserted to the surgical site by means of a trocar, and are manually controlled by surgeon through the control valves on the handpiece.
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
Not Found
Intended User / Care Setting
Operating room and by surgeons only.
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)
Non-clinical simulated use testing was performed to verify safety and effectiveness as compared to the predicate.
Performance testing, including irrigation and suction flow rate, verified that the abmedica irrigation/suction gravity system is substantially equivalent to the predicate Core Dynamics devices and raises no new issues of safety and effectiveness.
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.
CORE DYNAMICS, INC., Laparoscopic/suction/irrigation probe (K935826), CORE DYNAMICS, INC., Suction/irrigation "Y" tubing set w/trumpet valves (K930512)
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
§ 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
AB Medica s.a.s Alexandre Blanc Chief Executive Officer Les Petites Quarterees Mary-Su-Cher 18100 France
September 4, 2015
Re: K151822
Trade/Device Name: ab medica irrigation/suction gravity system Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: February 27, 2015 Received: July 6, 2015
Dear Mr. Blanc:
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 (reporting of medical
1
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 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/Resourcesfor You/Industry/default.htm. 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 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,
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
For Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151822
Device Name
abmedica Irrigation/Suction Gravity System
Indications for Use (Describe)
ab medica Irrigation/Suction Gravity System is indicated for use in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for "ab medica." The logo consists of a stylized, interconnected circular design on the left, followed by the text "abmedica" in a sans-serif font. A registered trademark symbol is present to the upper right of the text.
510(K) Summary K151822
510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Content in accordance with 21 CFR §807.92)
510(k) No: K151822
| Submitter: | Alexandre Blanc
Chief Operating Officer
abmedica, s.a.s
Les Petites Quarterées
18100 MERY-SUR-CHER, FRANCE
Tel: +33 (0) 2 48 51 59 93
Fax: +33 (0) 2 48 51 59 04
e-mail: blanc.alexandre@abmedica.fr |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel Donovan
Sr. Director., Quality & Regulatory Affairs
SurgiQuest, Inc.
488 Wheelers Farms Road
Milford, CT 06461
e-mail: ddonovan@surgiquest.com |
| Date Prepared: | August 25, 2015 |
| Trade Name: | ab medica irrigation / suction gravity system |
| Common Name: | Laparoscopic suction / irrigation system |
| Classification Name: | Endoscope and accessories under 21 C.F.R. 876.1500 |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Predicate Devices: | CORE DYNAMICS, INC., Laparoscopic/suction/irrigation
probe
(K935826)
CORE DYNAMICS, INC., Suction/irrigation "Y" tubing set w/trumpet
valves (K930512) |
| Device Description: | ab medica Irrigation/Suction Gravity System is intended for irrigation
and suctioning of the surgical field during laparoscopic surgery. This
device is intended to be used in the operating room and by surgeons
only.
The system consists of control handpiece pre-connected to a tubing set
and removable cannula. The tubing set and the 5 mm and 10 mm |
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Image /page/4/Picture/0 description: The image shows the logo for ab medica. The logo consists of a blue intertwined circular design on the left, followed by the text "ab medica" in blue. A registered trademark symbol is located to the upper right of the text.
510(K) Summary K151822
cannulae are single-use devices and provided in sterile condition. Only the 3 mm reusable cannula is provided non sterile. The system is used during laparoscopic surgery to deliver sterile irrigation fluids and/or to produce suction to evacuate blood and small tissue debris, and t o maintain a clear view of the surgical site. Irrigation and suctioning functions are provided through the cannula, which is inserted to the surgical site by means of a trocar, and are manually controlled by surgeon through the control valves on the handpiece.
Single-use tubing sets and cannulae are provided sterile .ETO sterility validation has been performed ISO 11135-1, Sterilization of health care products -Ethylene Oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; and ISO 10993-7, Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide sterilization residuals. A sterility assurance level (SAL) of 10-6 is achieved.
The shelf life of single use devices was verified in accordance with ISO 11607-1 Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2 Packaging for terminally sterilized medical devices: Part 2: Validation requirements for forming, sealing and assembly processes.
The reusable cannula is provided non-sterile and must be cleaned, disinfected, and sterilized by moist heat before each use. Cleaning validation was performed in accordance with A A M I TIR12 and AAMI TIR30. Sterility validation was performed in accordance with ISO 17665-1: Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, .to an SAL of 10 6
evacuate fluids, including blood and small tissue debris, to maintain a
abmedica Irrigation/Suction Gravity System is intended for irrigation Intended use: and suctioning of the surgical field during laparoscopic surgery. This device is intended to be used in the operating room and by surgeons only. Indications for use: abmedica Irrigation/Suction Gravity System is indicated for use in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures. Substantial abmedica irrigation/suction gravity system has the same intended use, Equivalence: general design and principle of functioning than the predicate. Both subject and predicate systems deliver sterile lavage solution and
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510(K) Summary K151822
clear view of the surgical site.
They are both composed of twin tubing set, control handpiece and cannula. Irrigation/ suction to / from the operative site are provided through the cannula.
Non-clinical simulated use testing was performed to verify safety and effectiveness as compared to the predicate.
Performance testing, including irrigation and suction flow rate, verified that the abmedica irrigation/suction gravity system is substantially equivalent to the predicate Core Dynamics devices and raises no new issues of safety and effectiveness.
Based on the intended use, technical characteristics and performance data, abmedica irrigation/suction gravity system is equivalent to the predicate device in terms of safety, effectiveness, and performance. Therefore, it is considered substantially equivalent to predicate.