(284 days)
Not Found
No
The summary describes a simple mechanical attachment for an endoscope and contains no mention of AI, ML, image processing, or any related concepts.
No
The device facilitates endoscopic therapy by maintaining the field of view and assisting with procedures like endoscopic mucosal resection, but it is an accessory and not therapeutic in itself. It does not directly treat or alleviate a disease or condition.
No
Explanation: The "Intended Use" section states the device is "for use with electrosurgical snares for endoscopic mucosal resection" and "for use in keeping the suitable depth of endoscopic field of view," indicating therapeutic and facilitative functions, not diagnostic ones.
No
The device description clearly states it is a "short transparent tube" to be attached to an endoscope, indicating it is a physical hardware component.
Based on the provided information, the Olympus Distal Attachment is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "short transparent tube" attached to an endoscope for use within the gastrointestinal tract. Its functions are related to facilitating endoscopic procedures (mucosal resection) and maintaining the field of view.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples or performing any diagnostic tests on samples taken from the patient.
The device is an accessory used during an endoscopic procedure, which is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) diagnostic test.
N/A
Intended Use / Indications for Use
The Olympus Distal Attachment is intended to be used for the following:
- a) for use with electrosurgical snares for endoscopic mucosal resection within the gastrointestinal tract; and
- b) for use in keeping the suitable depth of endoscopic field of view.
Product codes
FDS
Device Description
Olympus Distal Attachment has the shape of short transparent tube. Olympus Distal Attachment is to be attached to the distal end of the endoscope to facilitate endoscopic therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus America, Inc. Ms. Laura Storms-Tyler Director, Regulatory Affairs Two Corporate Center Drive Melville, NY 11747-3157
·JUL 2 7 2015
Re: K984358
Trade/Device Name: Olympus Distal Attachment (MH and MAJ Models) for Endoscopic Mucosal Resection Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS Dated (Date on orig SE Itr): August 31, 1999 Received (Date on orig SE ltr): September 2, 1999
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of September 17, 1999.
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. 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
1
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K 984358
510(k) Number (if known):
Device Name:
Indications for Use:
Olympus Distal Attachment
The Olympus Distal Attachment is intended to be used for the following:
- a) for use with electrosurgical snares for endoscopic mucosal resection within the gastrointestinal tract; and
- b) for use in keeping the suitable depth of endoscopic field of view.
Concurrence of CDRH, Office of Device Evaluation ODE
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| Labels | Values |
|---|---|
| 510(k) Number | K984358 |
(Optional Format 1-2-96)
3
K984358/Si
page 1 of 2
510(k) SUMMARY OLYMPUS DISTAL ATTACHMENT
A. Submitter's Name, Address, Phone and Fax Numbers
1. Manufacturer of the subject devices
Name & Address of manufacturer:
Registration No .: Address, Phone and Fax Numbers : 2951 Ishikawa-Cho, of R&D Department, Endoscope Division
Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku, 1-Chome, Shinjuku-ku, Tokyo 163-8610 Japan 8010047 Hachioji-shi, Tokyo 192-8507 Japan TEL 0426-42-5101 FAX 0426-46-2786
B. Name of Contact Person
Name: Address, Phone and Fax Numbers :
Laura Storms-Tyler Olympus Amcrica Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516) 844-5688 FAX: (516) 844-5416
C. Trade Name, Common Name and Classification Name
Trade Name: Olympus Distal Attachment MH-462, -463, -464, -465, -466, -483, -587, -588, -589, -590, -591, -592, -593, -594, -594, -595, -596, -597, -598, MAJ-289, -290, -291, -292, -293, -294, -295, -296, -297 Common Name : Transparent Cap Classfication Name: 21CFR 876.1500, Class II, Endoscope and accessories
D. Legally Marketed Device(s) which we claim Substantial Equivalence
| Manufacturer | Device Description | 510(k)# |
|---|---|---|
| -------------- | -------------------- | --------- |
Olympus MH-189
K954451 (Firdoscope Accessory for Model CF-140S. CF-Q1401/1 and CF-140L/I }
4
K 484358 $,
page 2 of 2
E. Description of the Device(s)
Olympus Distal Attachment has the shape of short transparent tube. Olympus Distal Attachment is to be attached to the distal end of the endoscope to facilitate endoscopic therapy.
R. Intended Use of the Device(s)
Olympus Distal Attachment has been designed to the distal end of the distal end of the endoscope to facilitate endoscopic therapy. Olympus Distal Attachment is used for the followings.
-
- Gastrointestinal mucosal resection (endoscopic mucosal resection)
-
- Keeping the suitable depth of endoscope's view field
-
- Helping the endoscope with being inserted into the gastrointestinal tract.
G. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)
1. Design
In order to maintain the electrical safety, the cap length of the subject devices is longer than the predicate MH-189.
-
- Matcrials
All the patient contacting materials have not been used in Olympus legally marketed Devices.
- Matcrials
H. Summary including a Bricf Discussion of Determination of Substantial Equivalence
-
- Design
The cap length supplies distance enough for the endoscopic therapy using the electrosurgical snares.
- Design
-
- Materials
The biocompatibility test reports show that new materials does not cause a problem.
- Materials
I. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, the subject devices do not incorporate any significant change that could affect the safety or effectiveness.