(255 days)
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.
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.
The provided text is a 510(k) premarket notification for an endoscope system. It details the device's description, indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
The document states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than proof of meeting specific performance acceptance criteria through independent studies.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the given information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific device performance metrics in the way that would typically be seen in a clinical study. Instead, it compares the physical and functional specifications of the akos endoscope system to several predicate devices.
| Feature | Predicate Range (Based on provided data from Olympus, Pentax, Vision Sciences, Fujinon, Welch Allyn) | akos biomedical, inc. (TBD) |
|---|---|---|
| Viewing Direction | Forward | Forward |
| Optical Field of View | 100-140 degrees | 125-135 degrees |
| Optical Depth of Field | 3-120mm | 5-100mm |
| Rigid Tip Diameter | 11.4-15.4mm | 13.7-14.2mm |
| Bending Tip Deflection | Up/Down (180-210 degrees), Right/Left (90-180 degrees) | Up/Down (180 degrees), Right/Left (160-180 degrees) |
| Bending OD | 11.2-14.3mm | 13.4-14mm |
| Insertion Tube Dia. | 11.4-14.0mm | 13.2-13.9mm |
| Insert. Working Length | 620-1770mm (note: some are given in cm) | 700-1750mm |
| Biopsy Channel ID | 2.8-4.3mm | 3.2-3.8mm |
| Total Length | 920-2100mm (incomplete data for some predicates) | 1020-2070mm |
| Op. Env. Amb. Temp | 10-40 deg C | 12-35 deg C |
| Op. Env. R Humidity | 15-85 % | 15-85 % |
| Atmospheric Pressure | 70-106 kPa (700-1060 mbar) | 70-106 kPa |
| Disposable Channels | Yes/No | Yes |
Note: The "acceptance criteria" here are inferred from the comparison to predicate devices, implying that performance within the range of existing, legally marketed devices for similar specifications is deemed acceptable for substantial equivalence. No specific quantitative performance targets (e.g., image resolution, diagnostic accuracy) are provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information available. The document does not describe a test set or clinical study with a specified sample size or data provenance. The clearance is based on substantial equivalence to predicate devices, not on a new clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- No information available. There is no mention of a test set or ground truth established by experts within this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information available. There is no mention of a test set or adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No information available. This document is for a medical device (endoscope), not an AI-powered diagnostic system, and it predates widespread AI application in this context (1997). No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an endoscope system, which is a tool used by a human operator for examination and procedures. It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- No ground truth discussed. The 510(k) submission primarily focuses on engineering specifications and intended use comparison to predicate devices for substantial equivalence, not on establishing a ground truth for diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth for it is relevant to this device's submission.
{0}------------------------------------------------
K 964131
JUN 27 1997 P 10]
akos biomedical, inc. 6450 Lusk Blvd., Suite 109 San Diego, CA 92121
510(k) SUMMARY February 10, 1997
akos
voice: 619.450.6767 fax: 619.450.9249 e-mail: akos@cts.com
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
akos biomedical, inc. Submitter's Name and Address: 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.
The endoscope system includes the endoscope with control head, a disposable Device Description: 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.
| 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 |
Predicate Device 510(k) Information:
{1}------------------------------------------------
K464131 Proj 3
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 I" as defined in the ANSVAAMI/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 forEvaluation 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 SafetyCollateral Standard: Safety Requirements for Medical Electrical Systems |
| IEC 601-1-2 | Medical Electrical Equipment, Part 1: General Requirements for SafetyCollateral Standard: Electromagnetic Compatibility - Requirements and Tests |
| IEC 601-2-18 | Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of EndoscopicEquipment |
| 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 ofIndustrial, 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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P3973
101V30 3TA210399 OT 2MO219A9M02 40 318A
| 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 | 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 | 8-65mm | 7-60mm | 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 160r/left | 180up/dn 160r/left | 180up/dn 160r/left | 210up/90dn&100r/left | 180up/dn 160r/left | 180up/dn 160r/left | 180up/dn 160r/left | 180up/dn 160r/left | 180up/dn 160r/left | |
| Bending OD | 13.4mm | 14mm | 13.8mm | 13.3mm | 11.2mm | 13.8mm | 11.5mm | 12.8mm | 12.8mm | 11.5mm | |
| 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 | 620mm | 640mm | 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 | 1015mm | 1020mm | 1470mm | 1620mm |
| Total Length | 1020mm | 2070mm | 920mm | 935mm | |||||||
| 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 | 700-1060mbars | 70-106kPa | |||||||
| Disposable Channels | Yes | Yes | No | No | No | No | No | No | No | No |
| Vision Sci. VS12000 | Vision Sci. S-F100 | Fujinon COL-ST2/LT2 | Fujinon SIG-ET2 | Fujinon COL-MP/LP2 | Fujinon SIG-GP | 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 observation | 4-120mm observ. | 3-100mm observ. | 5-100mm observ. | 5-100mm observ. | 5-100mm observ. | 5-100mm observ. | 3-100mm focal |
| Rigid Tip Diameter | 13.8mm | 14.0mm | 14.0mm | 14.0mm | 11.5mm | 11.8mm | 13.0mm | 13.0mm | 14.3mm | 13.5mm |
| Bending Tip Deflection | 180up/dn 160r/left | 180up/dn 150r/left | 180up/dn 160r/left | 180up/dn 160r/left | 180up/dn 160r/left | 180up/dn 160r/left | 180up/dn 180r/left | 180up/dn 180r/left | 180up/dn 160r/left | 180up/dn 150r/left |
| Bending OD | 14.0mm | 14.0mm | 14.0mm | 14.0mm | 11.5mm | 11.8mm | 13.0mm | 13.0mm | 14.3mm | 13.5mm |
| Insertion Tube Dia. | 12.8mm | 12.8mm | 12.8mm | 12.8mm | 11.5mm | 11.8mm | 13.0mm | 13.0mm | 14.0mm | 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 |
Page 3 of 3
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 1997
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 53 1 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 (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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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)
Robert R. Silling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_KG64131
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.