(60 days)
ab medica Irrigation/Suction Gravity System is indicated for use in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
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.
The provided text describes a medical device called the "ab medica irrigation/suction gravity system" and its 510(k) premarket notification to the FDA. The information primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
However, based on the non-clinical simulated use testing mentioned, we can infer the acceptance criteria and the study that was likely performed to demonstrate performance. The document explicitly states:
"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."
Given this, the acceptance criteria would be that the device's performance (specifically irrigation and suction flow rates) is substantially equivalent to the predicate device.
Here's an attempt to structure the answer based on the provided text, recognizing that some information is not directly available because the document focuses on regulatory approval rather than a detailed scientific study publication:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Irrigation flow rate is substantially equivalent to the predicate (Core Dynamics, Inc. Laparoscopic/suction/irrigation probe). | "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." (Specific numerical values for flow rates are not provided in this summary document). |
| Suction flow rate is substantially equivalent to the predicate (Core Dynamics, Inc. Laparoscopic/suction/irrigation probe). | "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." (Specific numerical values for flow rates are not provided in this summary document). |
| No new issues of safety and effectiveness compared to the predicate device. | "Performance testing...raises no new issues of safety and effectiveness." This implies the device performed similarly to the predicate without introducing new risks or underperforming. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated. The study involved "non-clinical simulated use testing." This typically refers to bench testing rather than patient data.
- Data provenance: "Non-clinical simulated use testing." This indicates lab-based testing rather than patient data from a specific country. It is not retrospective or prospective in the sense of clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device performance study (irrigation/suction flow rates) rather than an AI/ML diagnostic or prognostic study requiring expert ground truth for interpretation. The ground truth would be the measurement standards for flow rates.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for performance testing of physical device characteristics. Measurements of flow rates would presumably be adjudicated by comparing against predetermined engineering specifications or predicate device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an irrigation/suction system, not an AI/ML diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance testing refers to the device's functional characteristics (flow rates) in a simulated environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "irrigation and suction flow rate" performance testing, the ground truth would be established by:
- Validated measurement instruments: Devices used to measure fluid flow and suction pressure, calibrated against known standards.
- Predicate device performance: The performance of the legally marketed predicate device (Core Dynamics, Inc. probe and tubing set) as a benchmark for "substantial equivalence."
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a machine learning training set.
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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
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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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510(K) Summary K151822
510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Content in accordance with 21 CFR §807.92)
510(k) No: K151822
| Submitter: | Alexandre BlancChief Operating Officerabmedica, s.a.sLes Petites Quarterées18100 MERY-SUR-CHER, FRANCETel: +33 (0) 2 48 51 59 93Fax: +33 (0) 2 48 51 59 04e-mail: blanc.alexandre@abmedica.fr |
|---|---|
| Contact Person: | Daniel DonovanSr. Director., Quality & Regulatory AffairsSurgiQuest, Inc.488 Wheelers Farms RoadMilford, CT 06461e-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/irrigationprobe(K935826)CORE DYNAMICS, INC., Suction/irrigation "Y" tubing set w/trumpetvalves (K930512) |
| Device Description: | ab medica Irrigation/Suction Gravity System is intended for irrigationand suctioning of the surgical field during laparoscopic surgery. Thisdevice is intended to be used in the operating room and by surgeonsonly.The system consists of control handpiece pre-connected to a tubing setand removable cannula. The tubing set and the 5 mm and 10 mm |
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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.
§ 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.