(83 days)
The Accucore Biopsy Needle can be used for obtaining core and/or aspiration biopsies of various tissues (prostate, lung, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For breast biopsy this product is for diagnosis only - not for therapeutic use.
The design of the Inrad Accucore Biopsy Needle as well as the predicate device is referenced in the Comparison Information Section. The products are identically manufactured using the identical manufacturing systems, design and materials. Both needles are manufactured by Manan Medical products, Inc. The primary difference is packaging and sterilization which will be performed by Inrad. The device is manufactured from plastic(ABS) and stainless steel. The stainless steel is the only thing that has direct patient contact.
The provided text is a 510(k) summary for the Inrad Accucore Biopsy Needle. It asserts substantial equivalence to a predicate device rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for the device's performance cannot be extracted directly from this document.
The document focuses on demonstrating that the Inrad Accucore Biopsy Needle is substantially equivalent to the Manan Medical Products, Inc. Automatic Cutting Needle (K 974446)/(K895897). The argument for safety and effectiveness is based on the predicate device's established use and the identical manufacturing process.
Here's a breakdown of what can be inferred or explicitly stated from the provided text, and where information is missing:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated. The document does not define specific performance metrics or acceptance criteria for the Inrad Accucore Biopsy Needle. | Not Explicitly Stated. The document does not present quantitative performance data for the Inrad Accucore Biopsy Needle against any metrics. |
| Implicit Acceptance Criteria: Substantial equivalence to the predicate device (Manan Medical Products, Inc. Automatic Cutting Needle). This essentially means the device performs at least as well as the predicate for its intended use. | Implicit Reported Performance: The Inrad Accucore Biopsy Needle is "identically manufactured using the identical manufacturing systems, design and materials" as the predicate device, which has been "sold ... in the market place since 1989 and has proven to be safe and effective." The primary differences are packaging and sterilization. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. No specific test set or study data is presented for the Inrad Accucore Biopsy Needle.
- Data Provenance: Not applicable/Not provided in the context of a new study for this device. The claim of safety and effectiveness relies on the historical performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No new ground truth establishment is described for the Inrad Accucore Biopsy Needle.
4. Adjudication method for the test set:
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a biopsy needle, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used:
- Implicit Ground Truth: The established safety and effectiveness of the predicate device (Manan Medical Products, Inc. Automatic Cutting Needle) through its long-term use in the market since 1989. The regulatory body (FDA) accepted this as sufficient evidence for the predicate's performance.
8. The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not a learning algorithm or AI.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the Study (as described in the 510(k) summary):
The "study" presented here is based on the principle of substantial equivalence. The manufacturer (Inrad Incorporated) argues that its Accucore Biopsy Needle is fundamentally the same as its predicate device, the Manan Medical Products, Inc. Automatic Cutting Needle.
The key arguments for this equivalence are:
- Identical Indications for Use: Both devices are for obtaining soft tissue biopsies.
- Identical Design, Manufacturing Systems, and Materials: Both needles are manufactured by Manan Medical Products Inc. using the same processes and components (plastic (ABS) and stainless steel).
- Established Safety and Effectiveness of Predicate: The predicate device has been on the market since 1989 and is stated to have "proven to be safe and effective."
- Minimal Differences: The only stated differences are packaging and sterilization, which Inrad will perform on the bulk, non-sterile product purchased from Manan.
Therefore, the "proof" that the Inrad Accucore Biopsy Needle meets acceptance criteria (implicitly, the safety and effectiveness standards of a biopsy needle) is the demonstration of its identical nature to a legally marketed and established predicate device. No new performance study on the Inrad Accucore Biopsy Needle itself is described or required for this 510(k) submission.
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JUN 22 1998
981166
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92(c))
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- INDICATIONS: The indications or intended use for the Inrad Accucore Biopsy Needle as well as the predicate device, Manan Medical Products, Inc. Automatic Cutting Needle (K 974446)/(K895897) are the same. Both have the same indications, which is for obtaining soft tissue biopsies with a commercially available biopsy instrument. Manan has the original 510K (K895897) which had an indication for prostate biopsy. In 1997 Manan was awarded a 510K for the same product with broader indications for liver, kidney and other soft tissues for diagnostic evaluation.
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- DESIGN: The design of the Inrad Accucore Biopsy Needle as well as the predicate device is referenced in the Comparison Information Section. The products are identically manufactured using the identical manufacturing systems, design and materials. Both needles are manufactured by Manan Medical products, Inc. The primary difference is packaging and sterilization which will be performed by Inrad.
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- MATERIALS: The device is manufactured from plastic(ABS) and stainless steel. The stainless steel is the only thing that has direct patient contact Both products are identically manufactured by Manan Medical Products Inc. using the identical manufacturing systems, design and materials
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- SAFETY AND EFFECTIVENESS: Manan Medical Products Inc. has sold the identical device in the market place since 1989 and has proven to be safe and effective. The products are identically manufactured using the identical manufacturing systems, design and materials and there are no differences in safety and effectiveness.
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- DIFFERENCES: There are no differences between the Inrad Inc. Accucore Biopsy Needle and the Manan Medical Products Inc. Core Biopsy 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 standard Inrad systems.
Anne Armstrong
Director Quality Assurance/Regulatory Affairs
Inrad Incorporated 3956 44th St. SE Kentwood,MI 49512
Phone:(616) 554-7750 Ext. 102 Fax: (616) 554-7751
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1998
Ms. Anne Armstrong ·Director Ouality Assurance/Regulatory Affairs INRAD 3956 44th Street, S.E. Grand Rapids, Michigan 49512
Re: K981166 Trade Name: AccuCore Core Biopsy Needle Regulatory Class: II Product Code: KNW Dated: March 30, 1998 Received: March 31, 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 vour 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 (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Anne Armstrong
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) 594-4595. 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. Witter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (IF Known):
Device Name:
AccuCore Core Biopsy Needle Catalog Codes: 581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214
Indications for Use:
The Accucore Biopsy Needle can be used for obtaining core and/or aspiration biopsies of various tissues (prostate, lung, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For breast biopsy this product is for diagnosis only - not for therapeutic use.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | ----------------------------------------- |
OR
| Over-The-Counter-Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | 14981166 |
§ 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.