(70 days)
This Biopsy Instrument is used for drawing of osteomedullary substance or for explantation of bone marrow with a Snare-It Acquisition Cannula intended to contain the specimen during withdrawal from the needle's cannula.
The J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula consists of a J-style Bone Marrow Biopsy / Aspiration Needle with cap, providing the physician with greater torque than similar instruments, an ABS Ergonomic grip handle, which increases accuracy and speeds biopsy operation. It comes in 3 sizes; 8G x 4", 11G X 4", and 13G x 4". A Stylet, consisting of a locking mechanism to secure position in Biopsy needle, as well as a stainless steel cannula with a trocar tip for easier penetration into bone tissue. The Snare-it Marrow Acquisition Cannula is designed to allow the tissue to remain intact during removal. This allows for accurate analysis. It also allows additional sample collection without having to re-insert needle into the patient. A stainless steel, sample extractor, allows for convenient sample removal from the cannula. And finally, an extractor Cap.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria. Instead, it details a 510(k) premarket notification for a medical device (J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Acquisition Cannula).
The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The "Summary of Testing" section (Page 1) mentions:
- Biological qualification safety tests: Specifically, "Cytotoxicity Test" and "Intracutaneous Reactivity Test" were performed on materials used in the device.
- Acceptance: "These materials have met the testing requirements and were found to be acceptable for the intended use."
This indicates that biocompatibility was evaluated, and the materials met the necessary safety standards for their intended use. However, these are general material safety tests, not performance-based acceptance criteria for the device itself (e.g., accuracy, success rate of bone marrow acquisition, torque resistance, etc.). The document explicitly states the "subject device has the same Technological Characteristics as a legally marketed predicate device," implying that performance is assumed to be equivalent rather than independently proven against new, quantitative acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria or details about a study demonstrating performance in the way described in your request (e.g., sample size for test set, expert qualifications, MRMC study, etc.) because this information is not present in the provided text.
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JUN - 8 2011
K 110883.
Page 1 of 2
510(k) Summary
Regulatory Affairs Contact:
Muhamad Ansari Busse Hospital Disposables PO Box: 11067 75 Arkav Dr. Hauppauge NY 11788
Telephone:
Fax:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification Name:
Predicate Device:
Device Description:
PO Box: 11067
75 Arkay Dr.
Hauppauge NY 11788
631-435-4711 Ext: 254
631-435-2849
March 25, 2011
J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Acquisition Cannula
Biopsy Instrument
Class II, 21 CFR 876.1075, Product code KNW
Osteobell Bone Marrow Biopsy Needle
The J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula consists of a J-style Bone Marrow Biopsy / Aspiration Needle with cap, providing the physician with greater torque than similar instruments, an ABS Ergonomic grip handle, which increases accuracy and speeds biopsy operation. It comes in 3 sizes; 8G x 4", 11G X 4", and 13G x 4". A Stylet, consisting of a locking mechanism to secure position in Biopsy needle, as well as a stainless steel cannula with a trocar tip for easier penetration into bone tissue. The Snare-it Marrow Acquisition Cannula is designed to allow the tissue to remain intact during removal. This allows for accurate analysis. It also allows additional sample collection without having to re-insert needle into the patient. A stainless steel, sample extractor, allows for convenient sample removal from the cannula. And finally, an extractor Cap.
Section 5 Page 1
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Intended Use:
KI10.883
Page 2 of ②
This Biopsy Instrument is used for drawing of osteomedullary substance or for explantation of bone marrow with a Snare-It Acquisition Cannula intended to contain the specimen during withdrawal from the needle's cannula.
Technological Characteristics:
The subject device has the same Technological Characteristics as a legally marketed predicate device.
Summary of Testing:
All materials used in the fabrication of the J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Acquisition Cannula were evaluated through biological qualification safety tests.
The biocompatibility tests performed were:
- Cytotoxicity Test o
- ם Intracutaneous Reactivity Test
These materials have met the testing requirements and were found to be acceptable for the intended use.
The above statements are accurate representations of the device Busse intents to market. Based on all the testing and comparison Busse believes the subject device is substantially equivalent to the predicate device. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.
Conclusion:
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Busse Hospital Disposables % Mr. Muhamad Ansari P.O. Box 11067 75 Arkay Drive Hauppauge, New York 11788
JUN - 8 2011
Re: K110883
Trade/Device Name: J-Style Bone Marrow Biopsy/Aspiration Needle with Snare-it Marrow Acquisition Cannula
Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: March 25, 2011
Received: March 30, 2011
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. 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.
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Page 2 -- Mr. Muhamad Ansari
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Fon Dolo Nogo D.A
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): _ _ _ KITO 883
Device Name: J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-lt
Marrow Acquisition Cannula Marrow Acquisition Cannula
This biopsy instrument is used for drawing of osteomedullary substance or for explantation of bone marrow with a Snare-It Marrow Acquisition of bo intended to contain the specimen during withdrawal from the needle's cannula.
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Nil R. Ogden for nxm
Revision Sign-Off
sion of Surgical, Orthopedic, - Restorative Devices
510(k) Number K110883
Premarket Notification – Busse Hospital Disposables Section 4 Page 1
§ 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.