O-Mec 690 Series Laparoscopes

K201151 · Omec Medical, Inc. · GCJ · Jun 22, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K201151
• Device Name: O-Mec 690 Series Laparoscopes
• Applicant: Omec Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

Rigid, tubular, optical endoscope; used for visualization of internal anatomy during laparoscopic procedures. Device inputs: external light source illumination; optical image transmission via internal lens system. Device outputs: high-definition visual image of abdominal cavity/organs. Used in clinical settings (OR/clinic) by surgeons. Healthcare providers view output via connected imaging system to guide diagnostic/therapeutic interventions. Benefits: minimally invasive access to abdominal cavity for examination and surgery. Reusable, autoclavable device; requires manual/mechanical cleaning and steam sterilization before use.

Clinical Evidence

No clinical data. Bench testing only: functional performance (MTF, FOV, DOV, illumination, distortion), cleaning/sterilization validation (AAMI TIR30, ISO 17665-1), and electrical safety (IEC 60601-1, IEC 60601-2-18).

Technological Characteristics

Rigid endoscope; stainless steel 304/316L, optical glass, sapphire, epoxy glue, PEEK. 5mm/10mm diameters; 0°/30° view. Chromatic aberration correction (400-900nm). Autoclavable; reusable. Standards: ISO/TS 18339:2015, IEC 60601-1, IEC 60601-2-18, AAMI TIR30, ISO 17665-1, ISO 14971.

Indications for Use

Indicated for surgeons performing diagnostic and therapeutic laparoscopic minimally invasive procedures in the abdominal cavity via small skin punctures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Stryker Bariatric Laparoscope (K993045)

Reference Devices

• Schoelly Laparoscope (K143221)
• Stryker Laparoscope (K910132)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-size:10pt">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10pt">☐</span> 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: | [e-mail] |

## 2. Correspondent Information

| Contact: | Ms. Yolanda Smith |
|----------|-------------------------------|
| | Sr. Regulatory Consultant |
| | Smith Associates |
| Address: | 1468 Harwell Ave |
| | Crofton, MD 21114 |
| Phone: | [phone] |
| | [e-mail] |

#### 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)<br>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 of<br>Inserted 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 | Primary<br>Predicate Device | Reference<br>K143221 | Comments |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 510(k)<br>Number | K201151 | K993045 | K143221 | |
| Brand Name | 690 Series | Stryker Bariatric<br>Laparoscope | Schoelly<br>Laparoscope | |
| Parameter | SubjectDevice<br>K201151 | Predicate Device<br>K993045 | Predicate Device<br>K143221 | Comments |
| Regulation<br>Number | 876.1500 | 876.1500 | 876.1500 | Same |
| Regulation<br>Name | Laparoscope, general<br>& Plastic Surgery | Endoscope and<br>Accessories | Endoscope and<br>Accessories | Same |
| Product Code | GCJ | GCJ | GCJ | Same |
| Indications for<br>Use | The O-Mec 690 Series<br>Laparoscopes (690-<br>331000H, 690-<br>331030H, 690-<br>300500H, 690-<br>300530H) are intended<br>to be used by surgeons<br>in diagnostic and<br>therapeutic<br>procedures.<br>Laparoscopic minimally<br>invasive procedures<br>are performed in the<br>abdominal cavity by<br>means of small skin<br>punctures that allow<br>the insertion of the<br>laparoscope and<br>laparoscopic<br>instruments. | Laparoscopes are<br>intended to be used<br>by surgeons in<br>diagnostic and<br>therapeutic<br>procedures.<br>Laparoscopic<br>minimally invasive<br>procedures are<br>performed in the<br>abdominal cavity by<br>means of small skin<br>punctures that allow<br>the insertion of the<br>laparoscope and<br>laparoscopic<br>instruments. This<br>includes, but is not<br>limited to such uses<br>as gallbladder and<br>appendix removal,<br>hernia repair, gastric<br>bypass, laparoscopic<br>Nissen and<br>examination of the<br>abdominal cavity,<br>appendix, gallbladder<br>and liver. | The Schoelly<br>Laparoscope is<br>indicated for<br>examination of<br>body cavities,<br>hollow organs,<br>and canals, and<br>using additional<br>accessories, to<br>perform various<br>diagnostic and<br>therapeutic<br>procedures. | Similar |
| Principle of<br>Operation | Rigid, tubular, optical<br>instrument through<br>an incision in the<br>abdominal wall, used<br>to examine organs<br>inside the abdomen. | Rigid, tubular, optical<br>instrument through<br>an incision in the<br>abdominal wall, used<br>to examine organs<br>inside the abdomen. | Rigid, tubular,<br>optical instrument<br>through an<br>incision in the<br>abdominal wall,<br>used to examine<br>body cavities,<br>hollow organs,<br>and canals. | Similar |
| Models Feature Comparison | | | | |
| Parameter | Subject Device<br>K201151 | Predicate Device<br>K993045 | Predicate Device<br>K143221 | Comments |
| Catalog no | 690-331000H | 502-537-010 | 11.0031a | |
| Working<br>Length | 331mm | 300mm | 344mm | Similar |
| Maximum<br>Width of<br>inserted<br>Portion | 10.1mm | Ø10.0mm | 10.0mm | Similar |
| Direction of<br>view | 0° | 0° | 0° | Same |
| Catalog no | 690-331030H | 502-537-030 | 11.0043a | |
| Working<br>Length | 334mm | 300mm | 344mm | Similar |
| Maximum<br>Width of<br>inserted<br>Portion | 10.1mm | Ø10.0mm | 10.0mm | Similar |
| Direction of<br>view | 30° | 30° | 30° | Same |
| Catalog no | 690-300500H | 502-937-010 | N/A | |
| Working<br>Length | 301mm | 300mm | 312mm | Similar |
| Maximum<br>Width of<br>inserted<br>Portion | 5.5mm | Ø5.5mm | 5.0mm | Similar |
| Direction of<br>view | 0° | 0° | 0° | Same |
| Catalog no | 690-300530H | 502-937-030 | N/A | |
| Working<br>Length | 303mm | 300mm | 312mm | Similar |
| Maximum<br>Width of<br>inserted<br>Portion | 5.5mm | Ø5.5mm | 5.0mm | Similar |
| Direction of<br>view | 30° | 30° | 30° | Same |
| Optical System | | | | |
| Parameter | Subject Device<br>K201151 | Predicate Device<br>K993045 | Predicate Device<br>K143221 | Comments |
| Depth of Field | 25mm to 150mm | N/A | N/A | Information<br>not available |
| Field of View | 75° | N/A | Wide angle | Only wide<br>angle<br>referenced |
| Correct<br>Chromatic<br>Aberration | 400-900nm<br>wavelength range | N/A | N/A | Reference<br>predicate<br>K910132 |
| Material Choices | | | | |
| Body<br>Assembly | Stainless Steel 304<br>Stainless Steel 316L<br>Optical Glass<br>Sapphire<br>Epoxy Glue | Stainless Steel<br>Optical glass | Stainless Steel<br>304<br>Optical Glass | Similar |
| Eyepiece<br>Eyepiece is<br>standard:<br>ISO/TS<br>18339:2015-<br>11<br>Endotherapy<br>devices -<br>Eyepiece cap<br>and light guide<br>connector | Polyetheretherketone<br>(PEEK) | Yes | Yes | Same |
| Accessories | | | | |
| Cable Adapter<br>Compatibility | Wolf Adapter<br>Storz Adapter<br>ACMI Adapter | N/A | N/A | |
| Non- sterile<br>Delivered in<br>non-sterile<br>condition.<br>Needs to be<br>sterilized<br>before each<br>use. | Yes | Yes | Yes | Same |
| Autoclavable | Yes | Yes | Yes | Same |
| Reusable/<br>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 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional<br>Performance | Laparoscope<br>Performance Test | Marking | | Met acceptance criteria |
| | | Surface & Edges | | Met acceptance criteria |
| | | Connection | | Met acceptance criteria |
| | | Dimensions | | Met acceptance criteria |
| | | Cleanliness | | Met acceptance criteria |
| | | Aperture and Center<br>Focus | | Met acceptance criteria |
| | | Evenness of<br>Illumination |…