(86 days)
Not Found
No
The description focuses on the mechanical aspects of the needle and its use with an ultrasound endoscope for injection and aspiration. There is no mention of AI, ML, or any computational analysis of the ultrasound images or other data.
No
The device is used for delivery of injectable materials or aspiration, but it does not itself provide a therapeutic effect. It is a delivery/collection tool.
No
The device is used for delivery of injectable materials (therapeutic materials) and aspiration of tissues, which are interventional procedures, not diagnostic ones.
No
The device description clearly describes a physical needle and associated components used for injection and aspiration, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the delivery of injectable materials and fine needle aspirations (FNA) of tissues and masses. These are procedures performed on the patient's body, not on samples outside the body for diagnostic purposes.
- Device Description: The description details a needle used for injection and aspiration into the target site. It's a tool for accessing and manipulating tissue within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide diagnostic information based on in vitro testing. The aspiration is for obtaining a sample, but the device itself doesn't perform the diagnostic analysis of that sample.
IVD devices are typically used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. This device is used within the body for therapeutic delivery or sample collection.
N/A
Intended Use / Indications for Use
This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.
Product codes (comma separated list FDA assigned to the subject device)
FCG
Device Description
The Endoscopic Ultrasound Needle is offered in various needle gauges for injection or aspiration. This device is used in conjunction with an ultrasound endoscope to gain access to the target site. The needle which is dimpled for ultrasonic visualization is advanced into the target site for injection of therapeutic materials or aspiration. The device allows for adjustment of the length of the sheath and needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the needle which is removed for injection and aspiration. The device is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses within or adjacent to the GI 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)
Performance testing performed under simulated use conditions demonstrates that the Endoscopic Ultrasound Needle met the performance requirements of the expanded indications for use. The device will be substantially equivalent to currently cleared predicate devices.
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
Kобзэзо
COOK®
MEDICAL
COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. 744.0157 TOLL PREC: 800.245.4707 WW.COOKMEDICAL.COM
510(k) Summarv
FEB - 6 2009
Name: Address:
- Phone: Fax: Contact: Date:
Trade Name: Common Name: Classification Name:
Legally Marketed Devices:
Description of the Device:
Intended Use:
Cook Endoscopy 4900 Bethania Station Road Winston-Salem, North Carolina 27105 (336)744-0157 (336)201-5994 Scottie Fariole, Global Regulatory Affairs Specialist February 6, 2009
EchoTip Ultra Ultrasound Needle Endoscopic Ultrasound Needle Kit, Needle, Biopsy (21 CFR 876.1075, Product Code FCG)
Medi-Globe SonoTip II Ultrasound Needle System (K070129) PercuTx Injection/Aspiration Needle Probes with Control Handpiece (K994151) Endoscopic Ultrasound Needle (K934356)
The Endoscopic Ultrasound Needle is offered in various needle gauges for injection or aspiration. This device is used in conjunction with an ultrasound endoscope to gain access to the target site. The needle which is dimpled for ultrasonic visualization is advanced into the target site for injection of therapeutic materials or aspiration. The device allows for adjustment of the length of the sheath and needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the needle which is removed for injection and aspiration. The device is supplied sterile and intended for single use only.
This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.
| AORTIC INTERVENTION | CARDIOLOGY | CRITICAL CARE | ENDOSCOPY | PERIPHERAL INTERVENTION | SURGERY | UROLOGY | WOMEN'S HEALTH |
|---|---|---|---|---|---|---|---|
| --------------------- | ------------ | --------------- | ----------- | ------------------------- | --------- | --------- | ---------------- |
1
The expansion of the indications for use is not critical as supported by the Clinical Evidence specifically addressing the expanded target sites and delivery of injectable materials. The evidence discusses the expanded use of the device (or similar design) and the risks associated with that use. The Clinical Evidence supports the substantial equivalence of this device for the new indications for use.
1208333
Comparison of Characteristics:
We believe the proposed device to be substantially equivalent to currently marketed predicate devices as cleared by K070129, K994151 and K934356 in terms of Intended Use, Product Description, and Sterility,
Performance testing performed under simulated use conditions demonstrates that the Endoscopic Ultrasound Needle met the performance requirements of the expanded indications for use. The device will be substantially equivalent to currently cleared predicate devices.
Performance Data:
2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized representation of an abstract human figure. The figure is composed of three curved lines that form the shape of a person with arms outstretched. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are written vertically along the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 2009
Mr. Scottie Fariole Global Regulatory Affairs Specialist Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K083330
Trade/Device Name: Endoscopic Ultrasound Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: FCG Dated: November 6, 2008
Received: November 12, 2008
Dear Mr. Fariole:
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 such 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.
3
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 Incant 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry.suppo/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _KOダ 3330
Device Name: Endoscopic Ultrasound Needle
Indications for Use:
This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.
Prescription Use S (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aomi Whiter
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
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