(89 days)
The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
Olympus NA-10J-1 Aspiration Needle
This is a 510(k) premarket notification for a medical device (Olympus NA-10J-1 Aspiration Needle) and does not contain information about acceptance criteria or a study proving device performance in the context of AI/algorithm-based diagnostic devices.
The provided document is a regulatory submission for a physical medical device (an aspiration needle) and focuses on establishing substantial equivalence to a predicate device for market clearance. It primarily covers:
- Device Name and Intended Use: Specifies the Olympus NA-10J-1 Aspiration Needle for ultrasonically guided fine needle aspiration (FNA) of lesions.
- Regulatory Classification: Identifies the classification name (Gastroenterology-Urology Biopsy Instruments) and product code (78 FOG).
- Predicate Device: States the Olympus NA-1C Aspiration Needle (K904667) as the predicate.
- FDA Clearance Letter: Confirms the FDA's review and determination of substantial equivalence, allowing the device to be marketed.
Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/algorithm-based device is not present in this document. This document describes a traditional medical device, not an AI/ML diagnostic system.
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NOV 1 8 1997
P1071
510 (k) SUMMARY OLYMPUS NA-10J-1 ASPIRATION NEEDLE
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
| Device Name: | Olympus NA-10J-1 Aspiration Needle |
|---|---|
| Common/Usual Name: | Biopsy Instruments |
| Classification Name: | 21 CFR 876.1075Gastroenterology-Urology Biopsy Instruments |
| Predicate Devices: | Olympus NA-1C Aspiration Needle (K904667) |
| Prepared & Submitted By:(Contact Person) | Linda L. FavataOlympus America Inc.Endoscope DivisionTwo Corporate Center DriveMelville, New York 11747-3157(516) 844-5477 |
| Summary PreparationDate: | 07/25/97 |
Statement of Intended Use:
The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three heads, depicted in a minimalist, abstract style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 8 1997
Ms. Laura Storms-Tyler Director of Regulatory Affairs Endoscope Division Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157 Re: K973128
Olympus NA-10J-1 Aspiration Needle Dated: August 19, 1997 Received: August 21, 1997 Regulatory Class: II 21 CFR 8876.1075/Product Code: 78 FOG
Dear Ms. Storms-Tyler:
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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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) 594-4613. Additionally, for question 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
William Yu
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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Indications for Use Statement
Olympus NA-10J-1 Aspiration Needle
510(k) Number (if known):
Not assigned yet
Device Name:
Indications for Use:
The Olympus NA-10J-1 Aspiration Needle is specifically The Olympus to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of asphration (1 Nr.) Or bact (i.e., pancreatic masses, mediastinal masses, peri-rectal masses, and lymph nodes)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973128
12-07
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21CFR 801.109)
OR
Over-the Counter Use (Optional Format 1-2-96)
4
§ 868.5700 Nonpowered oxygen tent.
(a)
Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.