(74 days)
K 940024
Not Found
No
The summary describes a physical biopsy needle and its manufacturing process, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is used to guide a biopsy needle to the target lesion for obtaining samples, which is a diagnostic procedure, not a therapeutic one.
No
The device is described as an introducer needle used to guide a biopsy needle for obtaining samples, which is an interventional or procedural device, not one that directly diagnoses.
No
The device description explicitly states it is a "Co-axial Introducer Needle" and describes its manufacturing and materials, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "guide a biopsy needle to the target lesion for obtaining multiple biopsy samples." This describes a device used in vivo (within the body) for a surgical procedure (biopsy).
- Device Description: The description focuses on a needle used for guiding a biopsy. This is a surgical instrument, not a device used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device is used inside the body to facilitate the collection of those specimens.
N/A
Intended Use / Indications for Use
The device is used to guide a biopsy needle to the target lesion for obtaining multiple biopsy samples.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
K 940024
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92(c))
-
- INDICATIONS: The indications or intended use for the Inrad Co-axial Introducer Needle as well as the predicate device, Manan Medical Products, Inc. Co-axial Introducer Needle (K 940024) are the same. Both have the same indications, which is to guide biopsy needles to the target lesion for obtaining multiple biopsy samples.
-
- DESIGN: The design of the Inrad Co-axial Introducer Needle as well as the predicate device, Manan Medical Products is referenced in the Comparison Information Section. The products are identically manufactured using the same manufacturing systems, design and materials. Both needles are manufactured by Manan Medical Products, Inc. The primary differences are packaging and sterilization which will be performed by Inrad.
-
- MATERIALS: The device is manufactured from plastic and-stainless steel. The plastic hubs have no direct patient contact. The stainless steel is the only part of the device that has patient contact. Both products are identically manufactured by Manan Medical Products Inc. using the same manufacturing systems, design and materials
-
- SAFETY AND EFFECTIVENESS: Manan Medical Products Inc. has sold the identical device in the market place since 1994 and has proven it to be safe and effective. The products are identically manufactured using the same manufacturing systems, design and materials and there are no differences in safety and effectiveness.
-
- DIFFERENCES: There are no differences between the Inrad Inc. Coaxial Introducer Needle and the Manan Medical Products Inc. Co-axial Introducer Needle other than the source of packaging and sterilization. Inrad will be purchasing the identical product marketed by Manan, bulk and non-sterile, and then packaging and sterilizing the product using Inrad traditional systems.
Anne Armstrong
Anne Armstrong Director Quality Assurance/Regulatory Affairs
Inrad Incorporated 3956 44th St. SE Kentwood,MI 49512
Phone:(616) 554-7750 Ext. 102 (616) 554-7751 Fax:
Page 4
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1998
Ms. Anne Armstrong · Director, Quality Assurance/Regulatory Affairs INRAD. Inc. 3956 44th Street, S.E Kentwood, Michigan 49512
Re: K981721 Trade Name: Co-Axial Introducer Needle Regulatory Class: II Product Code: KNW Dated: May 14, 1998 Received: May15, 1998
Dear Ms. Armstrong:
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 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 (OS) 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 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.
2
Page 2 - Ms. Anne Armstrong
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
12981721 510 (k) Number (IF Known):
Device Name:
Indications for Use:
Co-axial Introducer Needle Catalog Codes: 611410, 611416, 611810, 611816
The device is used to guide a biopsy needle to the target lesion for obtaining multiple biopsy samples.
(Please Do Not Write Below This Line - Continue on Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L981721