ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE

K071756 · Pointe Conception Medical, Inc. · GCJ · Aug 15, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071756
• Device Name: ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
• Applicant: Pointe Conception Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endohub-1.0 Endoscopic Video Camera with Video Capture is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to; orthopedic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery. The Endohub-1.0 system allows for presentation of the endoscopic images onto video monitors.

Device Story

Endohub-1.0 Endoscopic Video Camera System consists of Camera Control Unit (CCU) and Camera Head; used with endoscope for visualization during minimally invasive surgery. Camera head utilizes 1CCD or 3CCD image sensors; employs fixed or variable focal length optics. System captures streaming video or still images for presentation on video monitors. Operated by surgical staff in clinical settings. Provides real-time visualization to assist surgeons during procedures; facilitates documentation via image capture. Steam-sterilizable camera head.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2 standards demonstrated.

Technological Characteristics

System includes CCU and camera head with 1CCD or 3CCD sensors. Supports fixed or variable focal length optics. Steam-sterilizable camera head. Complies with IEC 60601-1 (general safety), IEC 60601-2-18 (endoscopic equipment), and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for use as an endoscopic video camera in orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures, and as an accessory for microscopic surgery. No specific patient population or contraindications provided.

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

• Autoclavable 3-CCD Digital Camera System (K031098)

Submission Summary (Full Text)

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K071756

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Pointe Conception Medical, Inc 121 E. Mason Street Santa Barbara, California 93101

AUG 15 2007

June 20, 2007

## Modified -- 510(k) Summary As required by section 807.92(c)

# Endohub-1.0 Endoscopic Video Camera with Video Capture

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Pointe Conception Medical, Incorporated is hereby submitting the 510(k) summary of the Safety and Effectiveness for the Endohub-1.0 Endoscopic Video Camera System 510(k) number K071756

#### 1. Submitter [510(k) owner]

Pointe Conception Medical, Incorporated. 121 E. Mason Street Santa Barbara, California 93101

#### 2. Company Contact

William C. Haack VP. Enaineering 805-884-0403 Ext. 103 805-884-00260 [FAX] [e-mail]

#### 3. Submitted Device Information

Endoscopic Video Camera System Common Name: Endohub-1.0 Endoscopic Video Camera System with Video Capture Trade Name: Classification Name: Endoscope And/Or Accessories

#### Classification Information 4.

| Classification: | Class II |
|------------------------------|----------|
| Classification Regulation: | 876.1500 |
| Classification Product Code: | KOG |
| FDA Subsequent Product Code: | GCJ |

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K071756

### 5. Legally Marketed Predicate Devices

| Information on devices to which substantial equivalence is claimed | | | |
|--------------------------------------------------------------------|------------------------------------------|----------------------|----------------------------------|
| 510(k) Number | Device Description | Manufacturer | Substantial Equivalence Comments |
| K031098 | Autoclavable 3-CCD Digital Camera System | Linvatec Corporation | |

#### 6. Submitted Device Description

The Endohub-1.0 Endoscopic Video Camera System is a video camera system which consists of a Camera Control Unit [CCU] and Camera Head. The Endohub-1.0 Camera System is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head may be required prior to use. The camera head may be steam sterilized. The camera head may utilize 1CCD or 3CCD image sensors, and employ either fixed or variable focal length optics. The Endohub-1.0 Camera System incorporates an image capture system which allows for the capture of streaming video or still video images.

#### 7. Intended Use

The Endohub-1.0 Endoscopic Video Camera System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to; orthopedic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

The Endohub-1.0 system allows for presentation of the endoscopic images onto video monitors.

#### 8. Substantial Equivalence

The Endohub-1.0 Endoscopic Video Camera System is substantially equivalent to the predicate video camera system [K031098-Linvatec Corporation-Autoclavable 3-CCD Digital Camera System] in regard to indications for use, basic design, energy delivered, biocompatibility, performance, standards used, materials, safety and effectiveness and labeling.

There are no significant differences in the new device which raise issues of safety or effectiveness. Accordingly, Pointe Conception Medical, Incorporated believes that the Endohub-1.0 Endoscopic Video Camera System is substantially equivalent to the predicate devices currently on the market.

#### 9. Standards Compliance

The Endohub-1.0 Endoscopic Video Camera System has been tested and found to comply with the relevant international Medical Device Standards for Safety.

| IEC 60601-1 | Medical Electrical Equipment, General Standards |
|----------------|--------------------------------------------------------------------------------|
| IEC 60601-2-18 | Medical Electrical Equipment, Particular Requirements for Endoscopic Equipment |
| IEC 60601-1-2 | Medical Electrical Equipment, Requirements for Electromagnetic Compatibility |

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K07156

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William C. Haack VP Engineering Pointe Conception Medical 121 E. Mason Street Santa Barbara, California 93101 Phone: [phone] Ext. 103 805-884-0260 FAX: [e-mail]

REF: Endohub-1.0 Endoscopic Video System 510(k) summary

.

:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 15 2007

Pointe Conception Medical, Inc. % Mr. William C. Haack VP Engineering 121 E. Mason Street Santa Barbara, California 93101

Re: K071756

Trade/Device Name: Endohub-1.0 Endoscopic Video Camera with Video Capture Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 26, 2007 Received: June 28, 2007

Dear Mr. Haack:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. William C. Haack

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for Dattom

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K071756

# Indications for Use

510(k) Number (if known):

Device Name: Endohub-1.0 Endoscopic Video Camera with Video Capture

Indications For Use:

The Endohub-1.0 Endoscopic Video Camera with Video Capture is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to; orthopedic, laparoscopic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)
**(Division Sign-Off)**
Division of General, Restorative,
and Neurological Devices

510(k) Number: *k071706*

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