(20 days)
The ClearCam System is indicated to provide lens clearing during laparoscopic procedures.
The ClearCam System is a laparoscopic accessory lens clearing device consisting of a sheath and handle that slides over the laparoscope. The handle contains a wire connected to a wiper at the distal end of the sheath that provides lens clearing when activated. The device is intended to clear the intra-operative view of the surgical site during minimally invasive surgery by physically removing debris, blood, and bodily fluids from the laparoscope lens.
The provided text is a 510(k) premarket notification for the ClearCam System and describes its substantial equivalence to a predicate device, ClickClean (K170103). The document primarily focuses on demonstrating that the ClearCam System is as safe and effective as existing legally marketed devices, rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-driven medical device.
Therefore, the information required to answer many of the specific points about acceptance criteria and a study proving performance (especially in the context of AI and human readers) is not present in the provided document. The ClearCam System is a physical medical device (a laparoscopic accessory lens clearing device) and not an AI-based diagnostic or assistive system.
However, I can extract the information that is present and indicate where information is missing.
Here's the breakdown of what is available and what is not:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the ClearCam System
Based on the provided 510(k) summary, the ClearCam System is a physical medical device designed to clear laparoscopic lenses during surgery. The "acceptance criteria" and "study" described in the document are primarily focused on demonstrating substantial equivalence to a predicate device (ClickClean) through mechanical, functional, pre-clinical, and biocompatibility testing, rather than statistical performance metrics of an algorithm or human-in-the-loop study typical for AI/diagnostic devices.
1. Table of Acceptance Criteria and Reported Device Performance
For a physical device, "acceptance criteria" are typically defined by engineering design specifications and regulatory standards. The document reports "Pass" for all tested criteria, indicating that the device met these predefined specifications.
| Test Description | Method | Acceptance Criteria (Implicit: Pass) | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | |||
| Sterilization | ISO 14937:2009 Sterilization of healthcare products | Pass | Pass |
| Performance - Mechanical | In accordance with device performance specifications | Pass | Pass |
| Performance - Functional | In accordance with device performance specifications | Pass | Pass |
| Performance - Pre-Clinical | Functional testing set by the standard ISO 8600-1:1997 | Pass | Pass |
| Biocompatibility Testing | |||
| Cytotoxicity | ISO 10993-5 (in vitro cytotoxicity) | Pass | Pass |
| Hemocompatibility | ISO 10993-4 (selection of tests for interactions with blood) | Pass | Pass |
| Sensitization | ISO 10993-10 (irritation and skin sensitization) | Pass | Pass |
| Intracutaneous Reactivity | ISO 10993-10 (irritation and skin sensitization) | Pass | Pass |
| Systemic Toxicity (acute) | ISO 10993-11 (tests for systemic toxicity) | Pass | Pass |
| Pyrogenicity | ISO 10993-11 (tests for systemic toxicity) | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size for the mechanical and biocompatibility testing. It only states that "devices were tested." For these types of tests, sample sizes are typically determined by relevant ISO standards or internal quality procedures, but the specific number is not disclosed here.
- Data Provenance: Not applicable in the context of patient data for an AI/algorithm. The data provenance refers to materials and samples used for mechanical and biocompatibility testing of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the device is a physical tool for clearing lenses, not an AI or diagnostic device requiring expert interpretation of images/data to establish ground truth. The "ground truth" for this device's function is its ability to physically clean the lens and its biological compatibility.
4. Adjudication Method for the Test Set:
- Not applicable for this type of device and testing. Adjudication is relevant for subjective assessments, primarily in diagnostic accuracy studies involving multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This type of study is specifically for evaluating the impact of an AI system on human reader performance, which doesn't apply to a physical lens-clearing device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. The ClearCam System is a physical accessory, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by compliance with engineering design specifications, international standards (ISO), and successful completion of predefined functional and biocompatibility tests. For instance, "pass" for sterilization means it meets the defined sterility assurance level, and "pass" for functional testing means it performs its intended lens-clearing action as specified.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 19, 2020
ClearCam, LLC % Ms. Prithul Bom, BA.MBA Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite # 510k Saint Paul, Minnesota 55114
Re: K200228
Trade/Device Name: ClearCam System Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscopes, General & Plastic Surgery Regulatory Class: Class II Product Code: GCJ Dated: January 28, 2020 Received: January 30, 2020
Dear Ms. Prithul Bom:
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
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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 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 (QS) 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-device-safety/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 Advice (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
Enclosure
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Indications for Use
510(k) Number (if known) K200228
Device Name ClearCam System
Indications for Use (Describe)
The ClearCam System is indicated to provide lens clearing during laparoscopic procedures
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)
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Image /page/3/Picture/1 description: The image shows the logo for ClearCam. The logo consists of a stylized letter "C" made up of three concentric arcs in blue and black, followed by the word "CLEARCAM" in blue and black text. The "CLEAR" portion of the word is in blue, while the "CAM" portion is in black.
GENERAL INFORMATION 1.
| Submitter Name: | ClearCam Inc.Mr. Chris Idelson, PhD |
|---|---|
| Submitter Address: | 1601 Trinity St., Bldg BM/S Z-1400Austin, TX 78712 |
| Submitter Telephone: | (410) 897-2858 |
| Date Prepared: | October 9, 2019 |
| Trade Names: | ClearCam System |
| Common Name: | Laparoscope, General & Plastic Surgery |
| Classification: | Class II per:21 CFR 876.1500- Endoscope and accessories |
| Product Codes: | GCJ |
| Classification: | General & Plastic Surgery |
| Predicate Device(s): | Primary Predicate:ClickClean (K170103)Reference Device(s):EndoClear (K100346)Clearify (K062779) |
2. INDICATIONS FOR USE/INTENDED USE
The ClearCam System is indicated to provide lens clearing during laparoscopic procedures.
3. DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ClearCam System is a laparoscopic accessory lens clearing device consisting of a sheath and handle that slides over the laparoscope. The handle contains a wire connected to a wiper at the distal end of the sheath that provides lens clearing when activated. The device is intended to clear the intra-operative view of the surgical site during minimally invasive surgery by physically removing debris, blood, and bodily fluids from the laparoscope lens.
4. TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE SPECIFICATIONS
The technological characteristics and performance specifications of the ClearCam System is similar to the primary predicate device cleared under K170103. The intended use is identical. The differences in the principal of operation have been extensively performance tested so as not to raise new questions of safety and effectiveness. Performance testing data follows.
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Image /page/4/Picture/1 description: The image contains the logo for ClearCam. The logo consists of a stylized letter "C" made up of three concentric arcs, with the outer arc in blue and the inner two in black. To the right of the "C" is the word "CLEARCAM" in a sans-serif font, with "CLEAR" in blue and "CAM" in black.
ડ. Performance data
Mechanical Testing
The mechanical function and structural integrity of devices were tested to demonstrate that the design specifications from design inputs are fulfilled listed in Table 1.
| Table 1 | ||
|---|---|---|
| Test Description | Method | Result |
| Sterilization | ISO 14937:2009 Sterilization of healthcare products | Pass |
| Performance -Mechanical | In accordance with device performancespecifications | Pass |
| Performance -Functional | In accordance with device performancespecifications | Pass |
| Performance -Pre-Clinical | Functional testing set by the standardISO 8600-1:1997 | Pass |
Biocompatibility Testing
The biocompatibility evaluation and testing of the ClearCam System was conducted in accordance with the following standards and guidance, as recognized by the FDA Guidance - Use of International Standard ISO- 10993-1, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management process", dated 06-16-2016 listed in Table 2.
| Table 2 | ||
|---|---|---|
| Test Description | Method | Result |
| Cytotoxicity | ISO 10993-5, Biological evaluation ofmedical devices- Part 5: Tests for invitro cytotoxicity | Pass |
| Hemocompatibility | ISO 10993-4, Biological evaluation ofmedical devices - Part 4: Selection oftests for interactions with blood. | Pass |
| Sensitization | ISO 10993-10, Biological evaluation ofmedical devices- Part 10: Tests forirritation and skin sensitization | Pass |
| IntracutaneousReactivity | ISO 10993-10, Biologicalevaluation of medical devices - Part 10:Tests for irritation and skin sensitization | Pass |
| Systemic Toxicity(acute) | ISO 10993-11, Biological evaluation ofmedical devices- Part 11: Tests forsystemic toxicity. | Pass |
| Pyrogenicity | ISO 10993-11, Biological evaluation ofmedical devices - Part 11: Tests forsystemic toxicity | Pass |
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Image /page/5/Picture/1 description: The image contains the logo for ClearCam. The logo consists of a stylized letter "C" made up of three concentric arcs in blue and black, followed by the word "CLEARCAM" in blue and black. The wordmark is in a sans-serif font, with "CLEAR" in blue and "CAM" in black.
6. SUBSTANTIAL EQUIVALENCE
As established in this submission, the ClearCam System was shown to be substantially equivalent and have equivalent technological characteristics to its primary predicate device based on consideration of the following characteristics listed in Table 3.
| Table 3 | ||
|---|---|---|
| Device Name | Proposed Device | Primary Predicate Device |
| ClearCam System | Laparoscope Lens Shield Device(LENS) - ClickClean | |
| Device Attribute | (Subject Device) | (Legally Marketed: K170103) |
| Indications for Use | The ClearCam System is indicated to provide lens clearing during laparoscopic procedures. | Same |
| Where Used | Operating Room | Same |
| Prescription Only | Yes | Same |
| Target Patient | Patient under laparoscopic surgery | Same |
| Target User Population | Clinician who is qualified to perform a laparoscopic surgery | Same |
| Anatomical Site | Abdominopelvic cavity | Same |
| Method of Introduction | Introduced into abdominopelvic cavity via a trocar | Same |
| Biocompatibility | Externally communicating devices, in contact with tissue, with limited contact (≤ 24h) based on their intended use | Same |
| Product Code | GCJ | Same |
| Product Classification | Class II | Same |
| Material | Metal and Polyamide | Same |
| Diameter | 5mm, 5.5mm, 10mm Laparoscope | Same |
| Sterility | Single Use, Ethylene Oxide Sterilization, SAL of 10-6 | Same |
| Design Features / Components | Mechanical wiping of the distal lens to provide a clear view | Same |
7. CONCLUSION
Based on the intended use, technological characteristics, comparison to the predicate device and performance testing, the ClearCam System is substantially equivalent to the predicate device and raises no different question of safety or effectiveness.
§ 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.