(83 days)
Not Found
No
The device description focuses on mechanical modifications and the inclusion of a standard syringe, with no mention of AI/ML, image processing, or performance studies related to algorithmic analysis.
No.
The device is used for fine needle aspiration (FNA) which is a diagnostic procedure to collect samples for examination, not for treating a condition.
No
This device is an aspiration needle used for fine needle aspiration (FNA) which is a procedure to collect samples for diagnostic evaluation, but the needle itself is a sampling tool, not a diagnostic device that performs the analysis or diagnosis.
No
The device description clearly describes a physical, disposable aspiration needle and syringe, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract". This describes a procedure to collect a sample from within the body.
- Device Description: The device is an "ASPIRATION NEEDLE" and a "syringe". These are tools used to physically obtain a sample from a patient.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) to collect the specimen.
The device is a tool for sample collection, which is a step that precedes any potential in vitro diagnostic testing that might be performed on the collected sample.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with the ultrasound endoscope for ultrasonically quided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
Product codes (comma separated list FDA assigned to the subject device)
78 FCG
Device Description
DISPOSABLE ASPIRATION NEEDLE NA-200H is a modified version of NA-10J-1 Aspiration Needle, which was cleared #K973128. When compared with the predicate device, the following modifications have been made to the NA-10J-1 needle:
-
- The NA-200H is provided pre-assembled, sterile single use disposable.
-
- The NA-200H includes a sterile single use disposable syringe for aspiration.
The K12-MS2666 Syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-200H. These devices will be provided sterile single use. We are offering these devices together to improve convenience to the customer. The syringe to be included in the package has been cleared by FDA as a cardiologist or radiologist during angiographic or radiologic, it is intended to be used for aspiration in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes)
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)
When compared to the predicate device, Disposable Aspiration Needle NA-200H, VackLock Syringe and Stopcock does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
DEC 2 3 2002
K023272
Ogz1og2
SMDA 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR Section 807.92.
A. Submitter's Name, Address, Phone and Fax Number
| 1. Applicant: | Olympus Optical Co., Ltd.
2-3-1 Shinjuku Monolis Nishi-shinjuku
Shinjuku-ku, Tokyo, Japan, 163-0914 |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No. | 8010047 |
| Address, Phone and Fax
Numbers of R&D
Department Endoscope
Division: | 2951 Ishikawa-Cho,
Hachioji-shi, Tokyo 192-8507 Japan
Tel. 426-42-2891
Fax 426-42-2291 |
| 2. Initial Importer | Olympus America Inc.
Two Corporate Center Drive
Melville, NY 11747-3157 |
| Registration No. | 2429304 |
| 3. Contact Person | Laura Storms-Tyler
Director, Regulatory Affairs
Olympus America Inc.
Two Corporate Center Drive
Melville, NY 11747-3157
Tel (631)-844-5688
Fax (631)-844-5416 |
B. Device Name, Common Name
- Trade/Proprietary Name and Common Name 1. Trade Name: DISPOSABLE ASPIRATION NEEDLE NA-200H ASPIRATION NEEDLE Common Name:
-
- Class, Classification Number and Classification Name
| Classification Number | Classification Name | Class |
|---|---|---|
| 21 CFR 876.1075 | Gastroenterology-urology biopsy instrument | II |
3. Identification of Legally Marketed Devices Which We Claim Substantial Equivalence
| Description | Model No | Manufacturer | #K |
|---|---|---|---|
| ASPIRATION NEEDLE | NA-10J-1 | Olympus Optical Co., Ltd. | K973128 |
| VACLOK Syringe | - | Merit Medical System Inc. | K994253 |
| STOPCOCK(One-port manifold) | - | Merit Medical System Inc. | K934123 |
1
Kor 3272
pg 2 of r
C. Description of the Device(s)
NA-200H
DISPOSABLE ASPIRATION NEEDLE NA-200H is a modified version of NA-10J-1 Aspiration Needle, which was cleared #K973128. When compared with the predicate device, the following modifications have been made to the NA-10J-1 needle:
-
- The NA-200H is provided pre-assembled, sterile single use disposable.
-
- The NA-200H includes a sterile single use disposable syringe for aspiration.
The comparison table provided shows all other similarities and differences to the legally marketed device. Please refer to Attachment 5 for details.
VACLOK Syringe/ STOPCOCK
The K12-MS2666 Syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-200H. These devices will be provided sterile single use. We are offering these devices together to improve convenience to the customer. The syringe to be included in the package has been cleared by FDA as a cardiologist or radiologist during angiographic or radiologic, it is intended to be used for aspiration in this submission.
D. Intended Use of the Device(s)
This instrument has been designed to be used with the ultrasound endoscope for ultrasonically quided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
E. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, Disposable Aspiration Needle NA-200H, VackLock Syringe and Stopcock does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administratio 200 Corporate Boulevard Rockville MD 20850
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157
Re: K023272
Trade/Device Name: Disposable Aspiration Needle NA-200H Regulation Number: 21 CFR §876.1076 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: September 30, 2002 Received: October 1, 2002
Dear Ms. Storms-Tyler:
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 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 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy Chogden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
510(k) Number(if known):
02.327.2
Device Name: DISPOSABLE ASPIRATION NEEDLE NA-200H
Indications for Use:
This instrument has been designed to be used with the ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David G. Ingram
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number