ENDOSCOPE

K964131 · Akos Biomedical, Inc. · FAM · Jun 27, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964131
• Device Name: ENDOSCOPE
• Applicant: Akos Biomedical, Inc.
• Product Code: FAM · Gastroenterology, Urology
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The endoscope system is used to examine body cavities, hollow organs and canals, specifically the lower GI tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Story

Endoscope system for lower GI tract (colon) examination; includes control head, disposable assembly, imaging system, and pneumatically driven air/fluid system. Disposable assembly encompasses all inner passage channels to prevent contamination; eliminates need for mechanical valves in path. Lavage function provides water bolus through working channel to flush debris. Operated by clinicians in clinical settings. Provides visualization of colon; assists in diagnostic/therapeutic procedures. Benefits include reduced cross-contamination risk via single-use disposable channels.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Endoscope with control head, disposable assembly, imaging system, and pneumatic air/fluid system. Materials comply with USP classification of plastics and ISO 10993-1 biocompatibility standards. Sterilization via E-Beam radiation (SAL 10^-6) per ISO 11137. Complies with IEC 601-1, IEC 601-2-18, and electromagnetic compatibility standards (IEC 801, 1000-4).

Indications for Use

Indicated for examination of the lower GI tract (colon) and performance of diagnostic/therapeutic procedures in patients requiring colonoscopy.

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

• Olympus EVS-Endoscopic Video Image & Data Sys. (K853585)
• Pentax FS-34P2, Fiber Sigmoidoscope (K951576)
• Pentax ES-3800, Video Sigmoidoscope (K951577)
• Pentax EC-3800TL, Video Colonoscope (K951579)
• Pentax EC-3800L, Video Colonoscope (K951574)
• Vision Sciences, Inc. Flexible Video Sigmoidoscope System w/Disp. Sheath (K932843)
• Vision Sciences, Inc. Protective Sheath - Flexible Nasopharyngo-Larygnoscope (K933247)
• Vision Sciences, Inc. Flexible Fiberoptic Sigmoidoscope System (K921690)
• Vision Sciences, Inc. Disposable Protective Sheath (K921244)
• Fujinon, Inc. 200 Series Gastro-Intestinal Video System (K944759)
• Fujinon, Inc. Choledochoscope/Endoscope Modification (K933906)
• Welch Allyn, Inc. VS-200 Video Sigmoidoscope (K954704)
• Welch Allyn, Inc. Video Sigmoidoscope (K950429)
• Welch Allyn, Inc. CCD Endoscope (K801247)

Submission Summary (Full Text)

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964131
akos JUN 27 1997 P1n3

akos biomedical, inc.
6450 Lusk Blvd., Suite 109
San Diego, CA 92121

510(k) SUMMARY
February 10, 1997

voice: 619.450.6767
fax: [phone]
e-mail: [e-mail]

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter’s Name and Address: akos biomedical, inc.
Contact Person: Lacyne Avery
Trade or Proprietary Name: To Be Determined
Common Name: Endoscope
Classification Name: Endoscope
Device Class: Class II, within the Division of Gastroenterology-Urology Devices,
Regulation Number: 21CFR Part 876.1500 Procode: 78KOG

Indications for Use: The endoscope system is used to examine body cavities, hollow organs and canals, specifically the lower GI tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Description: The endoscope system includes the endoscope with control head, a disposable assembly, an imaging system, and a fluid and air system. The endoscope system features: 1) a smooth control head containing a minimal number of outside angles and joint crevices, 2) a single use disposable system encompassing all of the inner passage channels that start at the manifold, continue through the endoscope cavity, and seal onto the outside of the rigid distal tip, 3) a pneumatically driven air and fluid system eliminating the need for mechanical valves in the contamination path, and 4) a lavage function that provides a bolus of water through the working channel to loosen and flush debris from the field of view as the insertion tube advances through the colon.

**Predicate Device 510(k) Information:**

| Company Name | 510 (k) No. | 510(k) Description per CDRH Electronic Docket |
| --- | --- | --- |
| Olympus Corporation | K853585 | Olympus EVS-Endoscopic Video Image & Data Sys. |
| Pentax Precision Inst. | K951576 | FS-34P2, Fiber Sigmoidoscope |
| | K951577 | ES-3800, Video Sigmoidoscope |
| | K951579 | EC-3800TL, Video Colonoscope |
| | K951574 | EC-3800L, Video Colonoscope |
| Vision Sciences, Inc. | K932843 | Flexible Video Sigmoidoscope System w/Disp. Sheath |
| | K933247 | Protective Sheath - Flexible Nasopharyngo-Larygnoscope |
| | K921690 | Flexible Fiberoptic Sigmoidoscope System |
| | K921244 | Disposable Protective Sheath |
| Fujinon, Inc. | K944759 | 200 Series Gastro-Intestinal Video System |
| | K933906 | Choledochoscope/Endoscope Modification |
| Welch Allyn, Inc. | K954704 | VS-200 Video Sigmoidoscope |
| | K950429 | Video Sigmoidoscope |
| | K801247 | CCD Endoscope |

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K964131
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Sterilization: The Disposable Assembly will be marketed as “Sterile” - “Contents Are Sterile If Package Is Unopened and Undamaged”, it will NOT be labeled as “pyrogen free.” Sterilization with a SAL of 10-6 is to be performed by E-Beam radiation at TITAN Scan Systems, San Diego, California, using “Method 1” as defined in the ANSI/AAMI/ISO 11137-1994 “Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization.”

## Safety Performance Specification / Standards (Applicable Sections):

FCC 47 CFR Parts 0 to 19 (Part 18 is the applicable section)

UL 94 Tests for Flammability of Plastic Materials for Parts in Devices and Appliances

UL 1572 High Intensity Discharge Lighting Fixtures

UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

CSA C22.2 No. 0.4-M1982 Bonding and Grounding of Electrical Equipment

CSA C22.2 No. 601.1 Medical Electrical Equipment, General Requirements for Safety

G95-1 FDA Blue Book Memo - Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices

U.S.P. United States Pharmacopeia - Table 1. Classification of Plastics

ISO10993-1R Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing

ISO 11137 Sterilization of Health Care Products, Requirements for Validation and Routine Control, Radiation Sterilization.

IEC 320-1 Appliance Couplers for Household and Similar General Purposes

IEC 601-1 Medical Electrical Equipment, Part 1: General Requirements

IEC 601-1-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
Collateral Standard: Safety Requirements for Medical Electrical Systems

IEC 601-1-2 Medical Electrical Equipment, Part 1: General Requirements for Safety
Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

IEC 601-2-18 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Endoscopic Equipment

IEC 801-1 Electromagnetic Compatibility for Industrial-Process Measurement and Control Equipment, Part 1: General Introduction

IEC 801-5 Electromagnetic Compatibility for Industrial-Process Measurement and Control Equipment, Part 5: Surge Immunity Requirements

IEC 1000-4-2 Electromagnetic Compatibility (EMC), Part 4: Testing and Measurement Techniques, Section 2: Electrostatic Discharge Immunity Test Basic EMC Publication

IEC 1000-4-3 Electromagnetic Compatibility (EMC), Part 4: Testing and Measurement Techniques, Section 3: Radiated, Radio-Frequency, Electromagnetic Field Immunity Test

IEC 1000-4-4 Electromagnetic Compatibility (EMC)

EN 50082-1 Generic Immunity Standard for a Light Industrial Environment

EN 55011 Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio Frequency Equipment CISPR 11

EN 60950 Safety of Information Technology Equipment Including Electrical Business Equipment

4169-94 ASTM Standard Practice for Performance Testing of Shipping Containers and Systems

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K964131
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TABLE OF COMPARISONS TO PREDICATE DEVICES

| | akos (TBD) | akos (TBD) | Olympus CF-100S | Olympus CF-130S | Olympus E-GIF | Olympus E-CF | Pentax FS-34P2 | Pentax ES-3801 | Pentax EC-3801S2 | Pentax EC-3400M |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Viewing Direction | Forward | Forward | Forward | Forward | Forward | Forward | | | | |
| Optical Field of View | 135degrees | 125degrees | 140degrees | 140degrees | 113degrees | 133degrees | 120degrees | 120degrees | 120degrees | 120degrees |
| Optical Depth of Field | 5-100mm | 5-100mm | 5-100mm | 5-100mm | 8-85mm | 7-80mm | 3-100mm | 5-100mm | 5-100mm | 5-100mm |
| Rigid Tip Diameter | 13.7mm | 14.2mm | 15.4mm | 13.2mm | 11.4mm | 15.4mm | 11.5mm | 13.4mm | 13.4mm | 13.0mm |
| Bending Tip Deflection | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 210up/90dn&100r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left |
| Bending OD | 13.4mm | 14mm | | | 11.2mm | 13.8mm | | | | |
| Insertion Tube Dia. | 13.2mm | 13.9mm | 13.3mm | 13.3mm | 11.4mm | 13.8mm | 11.5mm | 12.8mm | 12.8mm | 11.5mm |
| Insert. Working Length | 700mm | 1750mm | 820mm | 840mm | 1025mm | I:1330 / L:1680mm | 700mm | 700mm | 1150mm | 1300mm |
| Biopsy Channel ID | 3.2mm | 3.8mm | 3.2mm | 3.2mm | 2.8mm | 3.2mm | 3.5mm | | | |
| Total Length | 1020mm | 2070mm | 920mm | 935mm | | | 1015mm | 1020mm | 1470mm | 1620mm |
| Op. Env. Amb. Temp | 12-35deg C | 12-35deg C | 10-40deg C | 10-40deg C | | | | | | |
| Op. Env. R Humidity | 15-85 % | 15-85 % | 30-85 % | 30-85 % | | | | | | |
| Atmospheric Pressure | 70-106kPa | 70-106kPa | 700-1080mbar | 70-106kPa | | | | | | |
| Disposable Channels | Yes | Yes | No | No | No | No | No | No | No | No |
| | Vision Sci. VS2000 | Vision Sci. S-F100 | Fujinon COL-ST2/LT2 | Fujinon SIG-ET2 | Fujinon COL-MP/LP2 | Fujinon SIG-QP | Fujinon EC7-MR/LR2 | Fujinon ES7-ER2 | Fujinon EC7-MT/LT2 | Welch Allyn FX-100 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Viewing Direction | Forward | Forward | Forward | Forward | Forward | Forward | Forward | Forward | Forward | Forward |
| Optical Field of View | 120degrees | 120degrees | 110degrees | 110degrees | 105degrees | 105degrees | 125degrees | 125degrees | 125degrees | 100degrees |
| Optical Depth of Field | | 3-100mm | 4-120mm observation | 4-120mm observ. | 4-120mm observ. | 3-100mm observ. | 5-100mm observ. | 5-100mm observ. | 5-100mm observ. | 3-100mm focal |
| Rigid Tip Diameter | | 13.8mm | 14.0mm | 14.0mm | 11.5mm | 11.8mm | 13.0mm | 13.0mm | 14.3mm | |
| Bending Tip Deflection | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 180r/left | |
| Bending OD | | | 14.0mm | 14.0mm | 11.5mm | 11.8mm | 13.0mm | 13.0mm | 14.0mm | |
| Insertion Tube Dia. | 12.8mm | 12.8mm | | | | | | | | 13.5mm |
| Insert. Working Length | 65cm | 65cm | 1010-1735mm | 765mm | 1475-1735 | 650mm | 1520-1770mm | 790mm | 1520-1770mm | 65cm |
| Biopsy Channel ID | 3.2mm | 3.2mm | 4.3mm | 4.3mm | 3.2mm | 3.2mm | 3.2mm | 3.2mm | 4.3mm | 3.2mm |
| Total Length | | | 1265-1990mm | 1020mm | 1730-1990mm | 980mm | 1850-2100mm | 1120mm | 1850-2100mm | |
| Op. Env. Amb. Temp | | | | | | | | | | |
| Op. Env. R Humidity | | | | | | | | | | |
| Atmospheric Pressure | | | | | | | | | | |
| Disposable Channels | Yes | Yes | No | No | No | No | No | No | No | No |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Lacyne Y. Avery
Director, Quality Assurance
and Regulatory Affairs
Akos Biomedical, Inc.
6450 Lusk Boulevard, Suite 109
San Diego, California 92121

Re: K964131
Video Endoscope System
Dated: April 11, 1997
Received: April 14, 1997
Regulatory class: II
21 CFR §876.1500/Product code: 78 FAM and FDF

Dear Ms. Avery:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat,
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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03/20/97 FRI 18:25 FAX [phone] akos biomedical, inc. 028

Page 1 of 1

K964131
510(k) Number (if known): ________________________
Video Endoscope System
Device Name: ________________________

Indications For Use:

The akos endoscope system is used to examine body cavities, hollow organs and canals, specifically the lower GI tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

(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 Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K964131

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)