(54 days)
The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-300500H, 690-300500H, are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are rigid endoscopes that are used to view a patient's internal anatomy for examination, diagnosis and therapy during laparoscopic procedures. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are available in two sizes: 5mm or 10mm diameters, with either 0° or 30° directions of view. O-Mec laparoscope provides a high definition image and can correct chromatic aberration in the 400-900nm wavelength range.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are delivered non-sterile and are reusable and fully autoclavable. O-Mec laparoscopes must be cleaned according to the Instructions of Use before each use.
The provided text describes the O-Mec Laparoscopes 690 Series and its substantial equivalence to predicate devices, but it does not contain information related to AI/ML device performance, acceptance criteria for AI/ML, or studies explicitly designed to prove an AI/ML device meets such criteria.
The document is a 510(k) Pre-Market Notification for a traditional medical device (laparoscopes). The "acceptance criteria" discussed are for the physical and functional performance of the laparoscope itself (e.g., optical performance, sterilization validation, electrical safety) in comparison to predicate devices, not for an AI/ML algorithm's diagnostic or predictive capabilities.
Therefore, I cannot extract the requested information, such as:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes used for test sets (for AI/ML), data provenance, etc.
- Number of experts, qualifications, and adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness study details (AI vs. human).
- Standalone performance of an AI algorithm.
- Type of ground truth used (for AI/ML).
- Sample size for the training set (for AI/ML).
- How ground truth for the training set was established (for AI/ML).
The document explicitly states: "Clinical testing was not performed with this device." and the "Summary of Non-Clinical Testing" focuses on hardware performance, cleaning, and safety. There is no mention of an AI/ML component or any associated performance metrics or studies.
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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 a seal with an abstract design. To the right of the seal, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".
June 22, 2020
OMEC Medical, Inc. % Ms. Yolanda Smith Sr. Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114 Re: K201151 Trade/Device Name: O-Mec Laparoscopes 690 Series (Models 690- 331000H, 690-300500H, 690-300530H)
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 14, 2020 Received: April 29, 2020
Dear Ms. Smith:
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.
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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) K201151
Device Name
O-Mec Laparoscopes 690 Series (Models, 690-331000H, 690-331030H, 690-300500H, 690-300530H)
Indications for Use (Describe)
The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-300500H, 690-300500H, are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
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
1. Submitter Information
| Company Name: | OMEC Medical Inc. |
|---|---|
| Company Address: | 2370 Qume Drive, Suite A |
| San Jose, CA 95131 | |
| Telephone: | 408-667-5307 |
| Fax: | 408-436-5557 |
| Contact Person: | Ms. Claire Nippress |
| Email: | clairen@omectech.us |
2. Correspondent Information
| Contact: | Ms. Yolanda Smith |
|---|---|
| Sr. Regulatory Consultant | |
| Smith Associates | |
| Address: | 1468 Harwell Ave |
| Crofton, MD 21114 | |
| Phone: | (410)451-0639 |
| Ysmith9746@fdaconsultants.com |
3. Date Prepared: June 17, 2020
4. Device Name
| Classification Name: | Laparoscope, General & Plastic Surgery |
|---|---|
| Common/Usual Name: | Laparoscope |
| Proprietary Name: | O-Mec Laparoscopes 690 Series (Models 690-331000H, 690-331030H, 690-300500H,690-300530H) |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Device Class: | Laparoscopes 21 CFR 876.1500 |
| Reviewing Panel: | General & Plastic Surgery |
| Basis for Submission: | New device 510k |
5. Predicate Device
Legally Marketed Equivalent Device
| Manufacturer | Brand Name | 510(k)Number | |
|---|---|---|---|
| Primary | Stryker Endoscopy | Stryker Bariatric Laparoscope | K993045 |
| Reference | Schoelly Fiberoptics GmbH | Schoelly Laparoscope | K143221 |
| Reference | Stryker Corporation | Stryker Laparoscope | K910132 |
6. Device Description
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O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are rigid endoscopes that are used to view a patient's internal anatomy for examination, diagnosis and therapy during laparoscopic procedures. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are available in two sizes: 5mm or 10mm diameters, with either 0° or 30° directions of view. O-Mec laparoscope provides a high definition image and can correct chromatic aberration in the 400-900nm wavelength range.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are delivered non-sterile and are reusable and fully autoclavable. O-Mec laparoscopes must be cleaned according to the Instructions of Use before each use.
| Catalog No. | Working Length | Maximum Width ofInserted Portion | Direction of View |
|---|---|---|---|
| 690-331000H | 331mm | 10.1mm | 0° |
| 690-331030H | 334mm | 10.1mm | 30° |
| 690-300500H | 301mm | 5.5mm | 0° |
| 690-300530H | 303mm | 5.5mm | 30° |
Table 1: Model Specifications - 690 Series
7.Indications for Use
The O-Mec Laparoscopes 690 Series (Models, 90-331030H, 690-331030H, 690-300530H) are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
8. Comparison of Technical Characteristics
The table below lists the comparison of the indications for use and technological characteristics of the subject and predicate device.
| Parameter | Subject Device | PrimaryPredicate Device | ReferenceK143221 | Comments |
|---|---|---|---|---|
| 510(k)Number | K201151 | K993045 | K143221 | |
| Brand Name | 690 Series | Stryker BariatricLaparoscope | SchoellyLaparoscope | |
| Parameter | SubjectDeviceK201151 | Predicate DeviceK993045 | Predicate DeviceK143221 | Comments |
| RegulationNumber | 876.1500 | 876.1500 | 876.1500 | Same |
| RegulationName | Laparoscope, general& Plastic Surgery | Endoscope andAccessories | Endoscope andAccessories | Same |
| Product Code | GCJ | GCJ | GCJ | Same |
| Indications forUse | The O-Mec 690 SeriesLaparoscopes (690-331000H, 690-331030H, 690-300500H, 690-300530H) are intendedto be used by surgeonsin diagnostic andtherapeuticprocedures.Laparoscopic minimallyinvasive proceduresare performed in theabdominal cavity bymeans of small skinpunctures that allowthe insertion of thelaparoscope andlaparoscopicinstruments. | Laparoscopes areintended to be usedby surgeons indiagnostic andtherapeuticprocedures.Laparoscopicminimally invasiveprocedures areperformed in theabdominal cavity bymeans of small skinpunctures that allowthe insertion of thelaparoscope andlaparoscopicinstruments. Thisincludes, but is notlimited to such usesas gallbladder andappendix removal,hernia repair, gastricbypass, laparoscopicNissen andexamination of theabdominal cavity,appendix, gallbladderand liver. | The SchoellyLaparoscope isindicated forexamination ofbody cavities,hollow organs,and canals, andusing additionalaccessories, toperform variousdiagnostic andtherapeuticprocedures. | Similar |
| Principle ofOperation | Rigid, tubular, opticalinstrument throughan incision in theabdominal wall, usedto examine organsinside the abdomen. | Rigid, tubular, opticalinstrument throughan incision in theabdominal wall, usedto examine organsinside the abdomen. | Rigid, tubular,optical instrumentthrough anincision in theabdominal wall,used to examinebody cavities,hollow organs,and canals. | Similar |
| Models Feature Comparison | ||||
| Parameter | Subject DeviceK201151 | Predicate DeviceK993045 | Predicate DeviceK143221 | Comments |
| Catalog no | 690-331000H | 502-537-010 | 11.0031a | |
| WorkingLength | 331mm | 300mm | 344mm | Similar |
| MaximumWidth ofinsertedPortion | 10.1mm | Ø10.0mm | 10.0mm | Similar |
| Direction ofview | 0° | 0° | 0° | Same |
| Catalog no | 690-331030H | 502-537-030 | 11.0043a | |
| WorkingLength | 334mm | 300mm | 344mm | Similar |
| MaximumWidth ofinsertedPortion | 10.1mm | Ø10.0mm | 10.0mm | Similar |
| Direction ofview | 30° | 30° | 30° | Same |
| Catalog no | 690-300500H | 502-937-010 | N/A | |
| WorkingLength | 301mm | 300mm | 312mm | Similar |
| MaximumWidth ofinsertedPortion | 5.5mm | Ø5.5mm | 5.0mm | Similar |
| Direction ofview | 0° | 0° | 0° | Same |
| Catalog no | 690-300530H | 502-937-030 | N/A | |
| WorkingLength | 303mm | 300mm | 312mm | Similar |
| MaximumWidth ofinsertedPortion | 5.5mm | Ø5.5mm | 5.0mm | Similar |
| Direction ofview | 30° | 30° | 30° | Same |
| Optical System | ||||
| Parameter | Subject DeviceK201151 | Predicate DeviceK993045 | Predicate DeviceK143221 | Comments |
| Depth of Field | 25mm to 150mm | N/A | N/A | Informationnot available |
| Field of View | 75° | N/A | Wide angle | Only wideanglereferenced |
| CorrectChromaticAberration | 400-900nmwavelength range | N/A | N/A | ReferencepredicateK910132 |
| Material Choices | ||||
| BodyAssembly | Stainless Steel 304Stainless Steel 316LOptical GlassSapphireEpoxy Glue | Stainless SteelOptical glass | Stainless Steel304Optical Glass | Similar |
| EyepieceEyepiece isstandard:ISO/TS18339:2015-11Endotherapydevices -Eyepiece capand light guideconnector | Polyetheretherketone(PEEK) | Yes | Yes | Same |
| Accessories | ||||
| Cable AdapterCompatibility | Wolf AdapterStorz AdapterACMI Adapter | N/A | N/A | |
| Non- sterileDelivered innon-sterilecondition.Needs to besterilizedbefore eachuse. | Yes | Yes | Yes | Same |
| Autoclavable | Yes | Yes | Yes | Same |
| Reusable/Reprocessable | Yes | Yes | Yes | Same |
Table 2: Comparator table for Subject Device
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Reference Predicate
K910132 is included as a reference predicate for the 400-900nm wavelength. The subject and reference device have very minor modifications to enhance near infrared images.
9. Summary of Non-Clinical Testing
The following performance data were provided in support of the substantial equivalence determination.
Table 3: Summary Table of Non-Clinical Testing
| Category | Test Title | Evaluation | Test Criteria | Results |
|---|---|---|---|---|
| FunctionalPerformance | LaparoscopePerformance Test | Marking | Met acceptance criteria | |
| Surface & Edges | Met acceptance criteria | |||
| Connection | Met acceptance criteria | |||
| Dimensions | Met acceptance criteria | |||
| Cleanliness | Met acceptance criteria | |||
| Aperture and CenterFocus | Met acceptance criteria | |||
| Evenness ofIllumination | Met acceptance criteria | |||
| Image Consistencyand Depth of Field | Met acceptance criteria | |||
| Image Focus andColor | Met acceptance criteria | |||
| Reflection and Runout | Met acceptance criteria | |||
| FOV/DOV | Met acceptance criteria | |||
| MTF | Met acceptance criteria | |||
| Transmission /Vignetting | Met acceptance criteria | |||
| Distortion | Met acceptance criteria | |||
| Runout | Met acceptance criteria | |||
| Sterilization/CleaningValidationStudies | Manual/MechanicalCleaning ValidationGLP Report | Cleaning validationwas performed forrecommendedprocedures and EnzoldetergentHemoglobin TestMicro BCA ProteinTestMEM Elution Test | AAMITIR30:2011 | The cleaning study wassuccessful in showingthe reduction of thephysical markers.This provides evidencethat laparoscopes canbe cleaned effectivelyusing the instructionsprovided. |
| Simulated UseCycles Final Report | Six simulated usecycles wereperformed. Each cycleincluded soiling,cleaning and | AAMITIR30:2011 | No soil was observed onany of the articles. | |
| Category | Test Title | Evaluation | Test Criteria | Results |
| sterilizationproceduresArticle oilingManual CleaningprocedureSterilization | ||||
| Steam Sterilizationvalidation FinalReport | Test article wasevaluated to a sterilityassurance level (SAL)of $≤10-6$ | ANSI/AAMI/ISO17665-1:2006/®2013,Annex D and thevalidationapproach outlinedin ANSI/AAMI/ISO14937:2009®2013,Annex D(Approach 3) | Results validated followingsterilization set points:Sterilizer Type: PrevacuumPreconditioning Pulses: 4Temperature: 132°C FullCycle Time: 4 minutesDry Time: 40 minutes TestArticle Configuration:Individually wrapped intwo layers of 1-plypolypropylene wrap(Halyard Health H200- 510(k)K082554) using sequentialenvelope foldingtechniques LoadConfiguration: One 20pound tray filled withmiscellaneous stainlesssteel dunnage was placedabove the test article inthe sterilizer | |
| ElectricalSafety | Medical electricalequipment Part 1generalrequirements forbasic safety andessentialperformance | Clause 5.7 HumidityPreconditioningTreatmentClause 5.9.2Determination ofAccessible partsClause 7.1.2 Legibilityof Marking Clause7.1.3 MarkingDurabilityClause 8.7 LeakagecurrentClause 8.8.3Dielectricstrength test | IEC 60601-12005+A1:2012 | Pass |
| Medicalelectricalequipment Part 2:particularrequirement forthe basic safetyand essentialperformance ofendoscopicequipment | IEC60601-2-18 | Pass | ||
| Category | Test Title | Evaluation | Test Criteria | Results |
| Clause 11.1,. 1w=ExcessivetemperaturesClause 15.3.2 PushtestClause 15.3.4.1 DroptestClause 15.3.6Mould stress relieftest | ||||
| HazardAnalysis | Medical devices -Application of risk | ISO 14971 2ndEdition R 2010 |
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Clinical testing was not performed with this device.
management to medical devices
10. Conclusion
The subject device is similar and or same for technological features to the predicate devices with slight differences for working length and width of inserted portion. The differences introduce not new issues of safety.
§ 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.