(189 days)
No
The description focuses on mechanical pumping and manual control via buttons, with no mention of AI/ML terms or functionalities.
Yes
The device is designed for controlled powered irrigation, resection of filmy adhesions, and peritoneal lavage during laparoscopic surgical procedures, which are all therapeutic interventions aimed at treating or managing a condition.
No
This device is designed for controlled powered irrigation and suction during laparoscopic surgical procedures, not for identifying the presence, nature, or extent of a medical condition.
No
The device description clearly outlines hardware components including a handpiece, tubing, a battery-powered mechanical pumping system, and probes. It is not solely software.
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 providing controlled powered irrigation and suction during laparoscopic surgical procedures. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a mechanical pumping system, handpiece, and tubing for delivering fluid and suction. This aligns with a surgical tool, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are designed to perform tests in vitro (outside the body).
The device described is a surgical instrument used in vivo (within the body) during a procedure.
N/A
Intended Use / Indications for Use
The CORE E3 Suction/Irrigator is designed to be used in conjunction with the CORE Trumpet Handpiece and probes to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
Product codes
GCJ
Device Description
The CORE E3TM Suction/Irrigator consists of a suction/irrigation handpiece and dual tubing that connects to a battery-powered mechanical pumping system to generate fluid output and can include a suction/irrigation probe. The device connects to a standard suction apparatus to deliver suction. Control of the flow (suction/irrigation) is generated by depressing the color-coded buttons on the handpiece. The handpiece can also be attached to separate compatible electrodes or probes, including reusable probes. The mechanical pumping system is powered with six (6) standard AAA alkaline batteries.
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
Healthcare facility/hospital
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
Bench Testing:
- Simulated use testing
- Functionality verification testing, including flow rate testing and accessory testing
Electrical safety and electromagnetic compatibility: - The system complies with the IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for EMC.
Biocompatibility: - Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Material-Mediated Pyrogenicity
- Acute Systemic Toxicity
- Hemocompatibility
Packaging and Sterilization: - Ethylene Oxide Sterilization Validation per ISO 11135
- Packaging Validation per ISO 11607-1
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
February 19, 2021
ConMed Corporation Tina Mornak Principal Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K202303
Trade/Device Name: CORE E3 Suction/irrigator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 13, 2020 Received: August 14, 2020
Dear Tina Mornak:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
Device Name CORE E3 Suction/Irrigator
Indications for Use (Describe)
The CORE E3 Suction/Irrigator is designed to be used in conjunction with the CORE Trumpet Handpiece and probes to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectory and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
| 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
CORE E3™ Suction/Irrigator
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CER 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K202303.
l. SUBMITTER
ConMed Corporation 525 French Road Utica, NY 13502 Company Contact: Tina Mornak Principal Regulatory Affairs Specialist t: 303-699-7600 x135086 christinamornak@conmed.com Date Prepared: January 21, 2021
II. DEVICE NAME
| Proprietary Name: | CORE E3™ Suction/Irrigator |
|---|---|
| Model Numbers: | CD8185-B – CORE E3 Suction/Irrigator, 5mm x 32cm Probe |
| CD81300-B - CORE E3 Suction/Irrigator, Handpiece Only | |
| Common Name: | Laparoscope, General & Plastic Surgery |
| Panel: | Gastroenterology/Urology |
| Product Code: | GCJ |
| Device Class: | II |
| Regulation Number: | 876.1500 |
lll. PREDICATE/LEGALLY MARKETED DEVICE
| Primary Device Name: | Hydro-Surg® Laparoscopic Irrigator |
|---|---|
| Company Name: | Davol Inc. |
| 510(k): | K961492 |
| Reference Device Name: | StrykeFlow |
| Company Name: | Stryker |
| 510(k): | K963646 |
IV. DEVICE DESCRIPTION
The CORE E3TM Suction/Irrigator consists of a suction/irrigation handpiece and dual tubing that connects to a battery-powered mechanical pumping system to generate fluid output and can include a suction/irrigation probe. The device connects to a standard suction apparatus to deliver suction. Control of the flow (suction/irrigation) is generated by depressing the color-coded buttons on the handpiece. The handpiece can also be attached to separate compatible electrodes or probes, including reusable probes. The mechanical pumping system is powered with six (6) standard AAA alkaline batteries.
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V. INTENDED USE / INDICATIONS FOR USE
The CORE E3TM Suction/Irrigator is designed to be used in conjunction with the CORE Trumpet Handpiece and probes to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The CORE E3™ Suction/Irrigator is similar to the predicate device in that the design of both include a battery-powered pump, dual tubing, trumpet handpiece, and optional probe. As with the predicate, the CORE E3™ Suction/Irrigator continues to function as a single use suction/irrigation device to provide controlled powered irrigation during laparoscopic surgical procedures. The main difference in the subject device from the predicate device is the number and size of batteries that powers the device, and the average delivered irrigation flow rates. The CORE E3™ Suction/Irrigator is safe and effective and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.
| Subject Device | Predicate Device | |
|---|---|---|
| CORE E3™ Suction/Irrigator | Hydro-Surg® Laparoscopic | |
| Irrigator | ||
| Indications for Use | The CORE E3 Suction/Irrigator is | |
| designed to be used in conjunction | ||
| with the CORE Trumpet Handpiece | ||
| and probes to provide controlled | ||
| powered irrigation/aspiration during | ||
| laparoscopic surgical procedures | ||
| (e.g., laparoscopic cholecystectomy | ||
| and laparoscopic gynecological | ||
| procedures). It may also be used for | ||
| resection of filmy adhesions (i.e., | ||
| hydrodissection) and peritoneal | ||
| lavage. | The Hydro-Surg Irrigator is designed | |
| to be used in conjunction with a | ||
| laparoscopic probe handle and tip to | ||
| provide controlled powered | ||
| irrigation/aspiration during | ||
| laparoscopic surgical procedures | ||
| (e.g., laparoscopic cholecystectomy | ||
| and laparoscopic gynecological | ||
| procedures). It may also be used for | ||
| resection of filmy adhesions (i.e., | ||
| hydrodissection) and peritoneal | ||
| lavage. | ||
| Design | Battery-powered pump, dual tubing, | |
| trumpet handpiece, and optional | ||
| probe. | Battery-powered pump, dual tubing, | |
| trumpet handpiece, and optional | ||
| probe. | ||
| Materials | 304 Stainless Steel, Polycarbonate, | |
| 420 Stainless Steel, EPDM Rubber, | ||
| ABS, and PVC. Six (6) AAA alkaline | ||
| batteries. | Plastic and metal components, | |
| material composition unknown. Eight | ||
| (8) AA alkaline batteries. | ||
| Performance Testing | Device performance was | |
| tested through bench testing | ||
| methodologies to demonstrate | ||
| functionality and that the | ||
| device met the minimum flow | ||
| rate of 1.2 L/min. Flow Rate range approx..1.52- | ||
| 2.08 L/min Electrical safety per IEC | ||
| 60601-1 Electromagnetic Compatibility | ||
| (EMC) per IEC 60601-1-2 | Device performance was tested | |
| through bench testing | ||
| methodologies to demonstrate | ||
| the device met the minimum | ||
| flow rate of 1.2 L/min. Flow Rate range approx..1.42- | ||
| 1.5 L/min Electromagnetic Compatibility | ||
| (EMC) per IEC 60601-1-2 | ||
| Single Use / Reusable | Single Use | Single Use |
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| Ethylene Oxide | Ethylene Oxide | |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of | |
| 10-6 | Sterility Assurance Level (SAL) of | |
| 10-6 | ||
| Environment Use | Healthcare facility/hospital | Healthcare facility/hospital |
| Principle of Operation | Battery powered mechanical | |
| pumping system | Battery powered mechanical | |
| pumping system |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
Bench testing was conducted on the CORE E3 device, including:
- Simulated use testing ●
- Functionality verification testing, including flow rate testing and accessory testing
Electrical safety and electromagnetic compatibility
Electrical safety and EMC testing were conducted on the CORE E3 device. The system complies with the IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for EMC.
Biocompatibility
The biocompatibility evaluation for the CORE E3 device was conducted in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part-1: Evaluation and testing within a risk management process and application of applicable principles detailed in FDA Guidance Use of International Standard ISO 10993-1. " Biological evaluation of medical devices – Part 1: Evaluation and Testing within a Risk Manaqement Process" (June 16, 2016). The following tests were completed:
- . Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity ●
- Material-Mediated Pyrogenicity ●
- Acute Systemic Toxicity ●
- Hemocompatibility
The CORE E3 device is categorized as external communicating with a body contact of tissue/bone/dentin. The duration of body contact is limited (