(27 days)
The I-Style Bone Marrow Aspiration Needle is to be used for the aspiration of bone marrow.
The I-Style Bone Marrow Aspiration Needle is intended for Aspiration of Bone Marrow.
The I-Style Bone Marrow Aspiration Needle consists of an 8ga - 15ga needle and a triple sharpened atraumatic tip stylet of corresponding size. The needle is manufactured in lengths upto 2" with an adjustable depth stopper and graduated scale which allow for the adjustment of the penetration length of the needle. A luer lock connection is provided in the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. The needle will be provided as sterile, single use, disposable device. They will be packaged individually or included in Bone Marrow Biopsy Tray.
The provided document describes the K061570 submission for the I-Style Bone Marrow Aspiration Needle. This is a 510(k) summary, which generally involves demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with acceptance criteria and a device performance study as one might see for novel high-risk devices or software as a medical device (SaMD).
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Same intended use | Met: "Same intended use" |
| Same flow rate | Met: "Same flow rate" |
| Same bonding strength | Met: "Same bonding strength" |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a "Summary of Tests performed to prove the substantial equivalence of the Aspiration Needles with the predicate device." This is a comparison-based assessment rather than a performance study against predefined numerical benchmarks.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "testing requirements" and "materials ... evaluated through biological qualification safety tests" and tests done to prove substantial equivalence. These are likely bench tests and material characterization, not patient-based clinical studies with a 'test set' of clinical data in the traditional sense.
- Data Provenance: Not explicitly stated. Given the nature of the device (a bone marrow aspiration needle) and the types of tests mentioned (biocompatibility, flow rate, bonding strength), the "data" would be generated from laboratory and bench testing, not clinical data from a specific country or collected retrospectively/prospectively from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For this type of device and submission, there is no mention or requirement for experts to establish a "ground truth" for a test set in the context of clinical data interpretation (e.g., from images). The evaluation is based on engineering and material performance specifications.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in the context of medical image interpretation or clinical outcome assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The I-Style Bone Marrow Aspiration Needle is a mechanical device, not an AI or diagnostic tool.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical medical instrument. The "tests" performed were for material safety and equivalence to a predicate device's mechanical characteristics.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "tests" performed, the ground truth would be based on established material specifications, engineering requirements, and performance data of the predicate device. For biocompatibility, established biological safety standards serve as the ground truth. For flow rate and bonding strength, the measured values are compared directly to the predicate device's characteristics. There's no "expert consensus," "pathology," or "outcomes data" ground truth in this context.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned or relevant for this device.
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SUMMARY
and the country of the comments of
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ASPIRATION NEEDLE
| Regulatory Affairs Contact: | Muhamad AnsariBusse Hospital DisposablesPO Box: 1106775 Arkay Dr.Hauppauge NY 11788 |
|---|---|
| Telephone: | 631-435-4711 Ext: 254 |
| Fax: | 631-435-2849 |
| Date Summary prepared: | May 31, 2006 |
| Product Trade Name: | I-Style Bone Marrow Aspiration Needle |
| Common Name: | Bone Marrow Biopsy Aspiration Needle. |
| Classification: | Class II, 21 CFR 868.5150 |
| Product Code: | KNW |
| Predicate Device: | Manan Bone Marrow Aspiration Needle |
| Device Description: | The I-Style Bone Marrow Aspiration Needleconsists of an 8ga - 15ga needle and a triplesharpened atraumatic tip stylet of correspondingsize. The needle is manufactured in lengths upto 2"with an adjustable depth stopper and graduatedscale which allow for the adjustment of thepenetration length of the needle. A luer lockconnection is provided in the molded needle handleto allow aspiration of bone marrow or blood by useof a standard surgical syringe.The needle will be provided as sterile, single use,disposable device. They will be packagedindividually or included in Bone Marrow BiopsyTray. |
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The I-Style Bone Marrow Aspiration Needle is to be used for the aspiration of bone marrow.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
Summary of Testing: All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay These materials have met the testing requirements and were found to be acceptable for the intended use. Summary of tests performed to prove the substantial
equivalence of the Aspiration Needles with the predicate device:
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- Same intended use
-
- Same flow rate
-
- Same bonding strength
Technological Characteristics: [21 CFR 807.92(a)(6)]
The subject device has the same Technological Characteristics as a legally marketed predicate device.
Conclusion: [21 CFR 807.92(b)(3)]
The above statements are accurate representations of the device Busse intents to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.
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Image /page/2/Picture/1 description: The image shows a logo with a stylized eagle in the center. The eagle is depicted with three curved lines forming its body and wings. The logo is encircled by a ring of text, though the text is too blurry to read. The overall design is simple and abstract.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2006
Busse Hospital Disposables % Mr. Muhamad Ansari Director. Regulatory Affairs P.O. Box 11067 Hauppauge, New York 11788-0920
Re: K061570
Trade/Device Name: I-Style Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: May 31, 2006 Received: June 6. 2006
Dear Mr. Ansari:
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.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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.
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Page 2 -- Mr. Muhamad Ansari
This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/cdrl/industry/support/index.html.
Sincerely yours,
Helen Levenson
Mark N. Molkerson
r Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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FDA 510(k) Premarket Notification
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: 1-Style Bone Marrow Aspiration Needle.
Indication for Use: The I-Style Bone Marrow Aspiration Needle is intended for Aspiration of Bone Marrow.
Prescription Use_ × (Per 21 CFR 801Subpart D) AND/OR
Over-The-Counter Use_ (Per 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulbert Lemon
Division of General, Restorative. and Neurological Devices
510(k) Number K061570
§ 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.