(126 days)
Not Found
No
The device description and intended use describe a mechanical bone marrow aspiration needle with no mention of software, algorithms, or any components that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is used for aspiration, which is a diagnostic or collection procedure, not a therapeutic one that treats a disease or condition.
No
The device is described as a needle used for aspiration of bone marrow or autologous blood, which are interventional procedures for collecting samples. There is no mention of it being used to diagnose a medical condition based on the collected samples or providing any diagnostic information itself.
No
The device description clearly states it is a physical needle with a stylet, depth gauge, and luer lock connection, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- SwannShidi Bone Marrow Aspiration Needle Function: The description clearly states the device is used for the aspiration (removal) of bone marrow or autologous blood from the body. It is a tool for obtaining a sample, not for performing a test on a sample.
- Lack of Testing Component: The device description focuses on the physical components of the needle and its function in obtaining a sample. There is no mention of any reagents, testing procedures, or analysis of the collected sample within the device itself.
The SwannShidi Bone Marrow Aspiration Needle is a surgical instrument used to collect a sample that could then be used for in vitro diagnostic testing, but the needle itself is not the diagnostic device.
N/A
Intended Use / Indications for Use
The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.
Product codes
KNW
Device Description
The SwannShidi Bone Marrow Aspiration Needle consists of a 15ga needle and an angled tip stylet of corresponding size. A depth gauge with graduated scale and additional locking mechanism allows for adjustment of the penetration section of the needle. A luer lock connection is provided to allow aspiration of bone marrow or autologous blood by use of a standard surgical syringe. The SwannShidi is a single use, disposable device that will be supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone marrow
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K121181
510(k) Summary
Summary of 510(k) Safety and Effectiveness
Submitted By:
Alliance Partners, LLC 121 Interpark Blvd, #601 San Antonio, TX 78216
Date:
August 13. 2012
Jennifer Palinchik Regulatory Consultant
(440) 933-8850
Contact Person:
Contact Telephone:
Device Trade Name: Device Classification Name: Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device:
SwannShidi Bone Marrow Aspiration Needle Gastroenterology-urology biopsy instrument Class II Gastroenterology/Urology 876.1075 KNW Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle (K061570) H.S. Hospital Service S.p.A. BMN "I" Type Marrow Biopsy Needle (K020987) Ranfac Corporation Goldenberg SNARECOIL Needle (K031344)
Device Description:
The SwannShidi Bone Marrow Aspiration Needle consists of a 15ga needle and an angled tip stylet of corresponding size. A depth gauge with graduated scale and additional locking mechanism allows for adjustment of the penetration section of the needle. A luer lock connection is provided to allow aspiration of bone marrow or autologous blood by use of a standard surgical syringe. The SwannShidi is a single use, disposable device that will be supplied sterile.
Intended Use:
The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.
Substantial Equivalence Information:
The design features, principles of operation, materials, indications for use, biocompatibility, and sterilization method of the SwannShidi are substantially equivalent to the predicate devices listed
AUG 2222012
1
K121181 Page 2 of 2
above. The minor technological differences between the SwannShidi and its predicate devices raise no issues of safety and effectiveness.
Predicate Comparison Summary Table:
| Item | SwannShidi | Busse Hospital
Disposables I-
Style Bone
Marrow | H.S. Hospital
Service BMN
"I" Type
Marrow Biopsy | Ranfac
Goldenberg
SNARECOIL
Needle |
|------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------|
| | | Aspiration
Needle | Needle | |
| Product
Code | KNW | KNW | KNW | KNW, FCG |
| Regulation
Name | Gastroenterology-
urology biopsy
instrument | Gastroenterology-
urology biopsy
instrument | Gastroenterology-
urology biopsy
instrument | Gastroenterology-
urology biopsy
instrument |
| Intended Use | for aspiration of
bone marrow or
autologous blood
by use of a
standard syringe | for aspiration of
bone marrow | for drawing of
osteomedullary
substance or for
explanation of
bone marrow | for obtaining a
percutaneous soft
tissue biopsy |
| Needle Size | 15 gauge | Same | Same | 11-16 gauge |
| Stylet | Yes | Yes | Yes | Yes |
| Angled Tip | Yes | Yes | Yes | Yes |
| Male luer
connection | Yes | Yes | Yes | Yes |
| Material-
Needle/Stylet | Stainless Steel | Same | Same | Same |
| Material-
Plastic
Components | Medical Grade
Plastic | Same | Same | Same |
| Sterilization
Method | Ethylene Oxide | Same | Same | Same |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alliance Partners, LLC % Ms. Jennifer Palinchik Regulatory Consultant 121 Interpark Boulevard, # 601 San Antonio, Texas 78216
AUG 2222012
Re: K121181
Trade/Device Name: SwannShidi Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: August 13, 2012 Received: August 14, 2012
Dear Ms. Palinchik:
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.
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
3
Page 2 - Ms. Jennifer Palinchik
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.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K121181
Device Name: SwannShidi Bone Marrow Aspiration Needle
Indications for Use:
The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Doyle formxm
(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121181