(158 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and physical performance of a biopsy needle, with no mention of AI or ML.
No
This device is for diagnostic purposes, specifically for obtaining tissue biopsies, not for treating a disease or condition.
No
A diagnostic device is used to identify a disease, condition, or injury. A biopsy needle is used to collect tissue, which is then analyzed by a separate diagnostic process (e.g., pathology) to make a diagnosis. The needle itself enables diagnosis but does not perform the diagnosis.
No
The device description explicitly states it is a "semiautomatic Biopsy needle" and lists physical components like a handle, stylet, tincer, and coring guide. The performance studies also focus on physical characteristics and interactions with tissue, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The described device is a biopsy needle. Its purpose is to collect a tissue sample from the body. It does not perform any diagnostic testing on that sample itself.
- Intended Use: The intended use is "for soft-tissue biopsy," which is the act of obtaining the sample.
- Testing Performed: The testing described focuses on the physical performance of the needle (penetration, shot, sample collection, MR compatibility, biocompatibility), not on the diagnostic analysis of the collected tissue.
While the tissue collected by this device may be used for subsequent in vitro diagnostic testing, the biopsy needle itself is a tool for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The semiautomatic Biopsy needle– BM is a sterile, spring loaded, disule biopsy system. It consists of the following maior components: handle stylet. tincer and coring nuide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast, kidney, liver, prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The purpose of the tests is to evaluate:
- the penetration of the needle
- The shot of the needle
- The quantity of the sample taken
- The quality/integrity of the sample taken
- MR tests for artificat
- Heating and induction test
- Biocompatibility
For the present report different Semiautomatic Biopsy Need. The 5 samples have been manufactured in 5 different lots. 14G, 16G and 18G biopsy needles were used. The lengths ranged from 100 mm. The testing was conducted after the validated EO sterilization of all devices. Therefore the tests were conducted on final devices
Description of the tests
- For the stylet perforation capacity, a biopsy needle in three different tissues (animal tissue and apples) according to the IFU. It isthen visually tested to ensure that the style tip could easily and effortlessly penetrate the tissue without causing tears or lacerations to create a good enty path for the cannula. The need in different tissues to assess the penetration capacity of the stylet tip.
- To test the shot of the needle the release mechanism of the biopsy device were triggered in the air as well as in the animal tissue. If the device works well, the cannula would cover the tip of the stylet that contains then otch completely. With this you can test if the spinq has enough power to push the cannula over the notch to cuttissue. This was conducted for the 10 mm and 20 mm notch.
- Different tissue samples were taken with biopsy devices for the 10mm and 20 mm notch. After that the collected samples was measured with aruler. The length was written down and the results were analyzed.
- The taken tissue samples in test 3 are observed under video microscope.
The samples were carefully observed to seeif they are cylindrical, intact and abundant. This was also done for 10 mm and 20 mm notch samples.
5&6) Furthermore MR-compatibility tests were conducted.
For the tests we used similar needles that use the biopsy devices and tested them under a 37 and 1.5T MRI-System. The needle is clearly visible under MR-quidance without any major attifacts. Furthermore no heating occured in any unit - Biocompatibility tests for Cytotoxicity, Sensitization, Acute Systemice Toxicity and Pyrogenicy were conducted.
Results:
- Needle penetration capacity: For all tested biopsy devices the insertion was optimal and conducted effortles sty with no difficulties at all. The acceptance criteria were met. This demonstrates that the devices works for penetration and is safe.
- Shot of the needle: For all tested hions v device the not the not the case for hotch notch sizes (10 mm and 20 mm ) From this it can be concluded that the spring is strong enough. The acceptance criteria were met and the device works and is safe.
- Quantity of the collected samples: Each sample for the liver and apple equals the notch size. For muscle tissue taken with the 10 mm notch the average length is 6.72 mm and for 20 mm notch 11.77 mm. Every sample was larger than the acceptance criteria of 5 mm and 10 mm. Therefore the criteria is met. The average sample size over all tissues is 8.82mm for the 10 mm notch. The device is therefore is therefore effective to take proper samples.
- Quality/integrity of the collected samples: All samples are cylindrical, intact and abundant. The acceptance criteria were met. Because of this the device is effective and safe.
Based on the performed tests the proposed device is as safe and as effective as the predicate device. Furthe more the average sample size of the collected tissue is larger for the proposed device. Proposed device: 10 mm notch: 8.82 mm samples, 20 mm notch: 17.22 mm samples
Predicate device: 10 mm notch 7 cm samples, 20 mm notch: 13 mm samples
5&6. Based on the MR-tests the device is MR-compatible. The new any major artificats and is cleary visible especially compared to the needle with stainless steel. In addition no heating or cured during these tests. - Biocompatibility were proofen with the conducted tests.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ITP Innovative Tomography Products GmbH Dominik Fraemke Project Manager Universitaetsstr. 136 Bochum. 44799 Germany
January 20, 2023
Re: K222462
Trade/Device Name: Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semiautomatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: October 24, 2022 Received: October 24, 2022
Dear Dominik Fraemke:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Colin K. Chen -S
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
| Device Name | Semi-automatic Biopsy-Needle (BIM 18/20);
Semi-automatic Biopsy-Needle (BIM 18/15);
Semi-automatic Biopsy-Needle (BIM 18/10);
Semi-automatic Biopsy-Needle (BIM 16/20);
Semi-automatic Biopsy-Needle (BIM 16/15);
Semi-automatic Biopsy-Needle (BIM 16/10);
Semi-automatic Biopsy-Needle (BIM 14/20);
Semi-automatic Biopsy-Needle (BIM 14/15);
Semi-automatic Biopsy-Needle (BIM 14/10) | | |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Indications for Use (Describe) | The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate). | | |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | |
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3
| 510(k)#: K222462 | 510(k) Summary | Prepared on: 2022-12-22 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | ITP Innovative Tomography Products GmbH | ||
| Applicant Address | Universitaetsstr. 136 Bochum 44799 Germany | ||
| Applicant Contact Telephone | +4923454621940 | ||
| Applicant Contact | Dr. Heinz-Wemer Henke | ||
| Applicant Contact Email | henke@innotom.com | ||
| Correspondent Name | ITP Innovative Tomography Products GmbH | ||
| Correspondent Address | Universitaetsstr. 136 Bochum 44799 Germany | ||
| Correspondent Contact Telephone | +4923454621940 | ||
| Correspondent Contact | Mr. Dominik Fraemke | ||
| Correspondent Contact Email | fraemke@innotom.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Semi-automatic Biopsy-Needle (BIM 18/20); | ||
| Semi-automatic Biopsy-Needle (BIM 18/15); | |||
| Semi-automatic Biopsy-Needle (BIM 18/10); | |||
| Semi-automatic Biopsy-Needle (BIM 16/20); | |||
| Semi-automatic Biopsy-Needle (BIM 16/15); | |||
| Semi-automatic Biopsy-Needle (BIM 16/10); | |||
| Semi-automatic Biopsy-Needle (BIM 14/20); | |||
| Semi-automatic Biopsy-Needle (BIM 14/15); | |||
| Semi-automatic Biopsy-Needle (BIM 14/10) | |||
| Common Name | Gastroenterology-urology biopsy instrument | ||
| Classification Name | Instrument, Biopsy | ||
| Regulation Number | 876.1075 | ||
| Product Code | KNW | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | ||
| K130616 | Semi-Automatic Biopsy Needle | ||
| KNW | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The semiautomatic Biopsy needle– BM is a sterile, spring loaded, disule biopsy system. It consists of the
following maior components: handle stylet. tincer and coring nuide.
4
Intended Use/Indications for Use
The biopsy-needle is intended for soft-tis sue biopsy (such as breast, kidney, liver, prostate).
Indications for Use Comparison
The proposed devices are working equivalently to the predicate device. They are all intended to obtain diagnostic samples of tissue for histological examination during a percutaneaous biopsy procedure. They differ only in optical design aspects. In addition the proposed device is MR-compatible.
Technological Comparison
The BM is identical or similar in technology, design and material to the predicate devices are sterile and for single-use. The only difference between the two devicesare the materials of the needles as well as optical design aspects. Based on the same intended use and the similarities in technology, design and materials the proposed devices are substantially equivale/ reference devices. Biocompatibility, MR-testing, sterility and packaging demonstrate the safety and effectiveness of the proposed device
Non-Clinical and/or Clinical Tests Summary & Conclusions
The purpose of the tests is to evaluate:
-
the penetration of the needle
-
The shot of the needle
-
The quantity of the sample taken
-
The quality/integrity of the sample taken
-
MR tests for artificat
-
Heating and induction test
-
Biocompatibility
For the present report different Semiautomatic Biopsy Need. The 5 samples have been manufactured in 5 different lots. 14G, 16G and 18G biopsy needles were used. The lengths ranged from 100 mm. The testing was conducted after the validated EO sterilization of all devices. Therefore the tests were conducted on final devices
Description of the tests
-
For the stylet perforation capacity, a biopsy needle in three different tissues (animal tissue and apples) according to the IFU. It isthen visually tested to ensure that the style tip could easily and effortlessly penetrate the tissue without causing tears or lacerations to create a good enty path for the cannula. The need in different tissues to assess the penetration capacity of the stylet tip. 2) To test the shot of the needle the release mechanism of the biopsy device were triggered in the air as well as in the animal tissue. If the device works well, the cannula would cover the tip of the stylet that contains then otch completely. With this you can test if the spinq has enough power to push the cannula over the notch to cuttissue. This was conducted for the 10 mm and 20 mm notch.
-
Different tissue samples were taken with biopsy devices for the 10mm and 20 mm notch. After that the collected samples was measured with aruler. The length was written down and the results were analyzed.
-
The taken tissue samples in test 3 are observed under video microscope.
The samples were carefully observed to seeif they are cylindrical, intact and abundant. This was also done for 10 mm and 20 mm notch samples.
5&6) Furthermore MR-compatibility tests were conducted.
For the tests we used similar needles that use the biopsy devices and tested them under a 37 and 1.5T MRI-System. The needle is clearly visible under MR-quidance without any major attifacts. Furthermore no heating occured in any unit 7) Biocompatibility tests for Cytotoxicity, Sensitization, Acute Systemice Toxicity and Pyrogenicy were conducted.
1.Needle penetration capacity
For all tested biopsy devices the insertion was optimal and conducted effortles sty with no difficulties at all. The acceptance criteria were met. This demonstrates that the devices works for penetration and is safe.
2.Shot of the needle.
For all tested hions v device the not the not the case for hotch notch sizes (10 mm and 20 mm ) From this
Page 2 of 3
21 CFR 807.92(a
21 CFR 807 92(a)(5)
21 CFR 807.92(a)(6)
5
============================================================================================================================================================================= it can be concluded that the spring is strong enough. The acceptance criteria were met and the device works and is safe.
3.Quantity of the collected samples
Each sample for the liver and apple equals the notch size. For muscle tissue taken with the 10 mm notch the average length is 6.72 mm and for 20 mm notch 11.77 mm. Every sample was larger than the acceptance criteria of 5 mm and 10 mm. Therefore the criteria is met. The average sample size over all tissues is 8.82mm for the 10 mm notch. The device is therefore is therefore effective to take proper samples.
4.Quality/integrity of the collected samples
All samples are cylindrical, intact and abundant. The acceptance criteria were met. Because of this the device is effective and safe.
Based on the performed tests the proposed device is as safe and as effective as the predicate device. Furthe more the average sample size of the collected tissue is larger for the proposed device. Proposed device: 10 mm notch: 8.82 mm samples, 20 mm notch: 17.22 mm samples
Predicate device: 10 mm notch 7 cm samples, 20 mm notch: 13 mm samples
5&6.
Based on the MR-tests the device is MR-compatible. The new any major artificats and is cleary visible especially compared to the needle with stainless steel. In addition no heating or cured during these tests.
- Biocompatibility were proofen with the conducted tests.
Conclusion:
The Semi-automatic Biopsy-Needle functions as intended. The results drawn from the non-dinical tests as well as the literature presented in this 510(k) submission demonstrate the proposed device is as safe, effectiveand performs as well as the legally marketed predicate device. The proposed device has a similiar intended use and design characteristics. The M-compatbility were proven with MR tests and the different needlemateliality. Therefore the proposed device is substantially equivalent to the predicate device.