(77 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an "aspiration needle" intended for the "aspiration of bone marrow or autologous blood." This indicates a diagnostic or collection purpose, not a therapeutic one where the device itself treats a condition or disease.
No
The device is described as an aspiration needle for collecting bone marrow or autologous blood, which is a collection tool rather than a diagnostic tool. Diagnostic devices are typically used to identify or determine the nature of a disease or condition.
No
The device description explicitly states it consists of a needle, cannula, and syringe, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration of bone marrow or autologous blood. This is a procedure to collect a sample from the body.
- Device Description: The device is a needle designed for this aspiration process.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze the collected sample, detect specific substances, or provide any diagnostic information in vitro (outside the body). IVDs are typically used to perform tests on biological samples to diagnose conditions, monitor health, or screen for diseases.
This device is a tool for collecting a biological sample, which is a necessary step before any potential in vitro diagnostic testing might be performed on that sample. However, the device itself does not perform the diagnostic test.
N/A
Intended Use / Indications for Use
The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
Product codes
KNW
Device Description
The Marrow Cellution Bone Marrow Aspiration Needle consists of a Ranfac Aspiration Needle with Adjustable Guide as well as an additional Aspirator Cannula and a 10ml Syringe.
The Marrow Cellution Bone Marrow Aspiration Needle is a single use disposable needle that allows the medical device professional the ability to aspirate from the sides of the needle without aspirating from the needle tip. This allows the needle to be retracted during aspiration ensuring aspirate will not be compromised by the end being open to an area that has already had aspirate removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical device professional
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
Design verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the Marrow Cellution Bone Marrow Aspiration Needle performed in an equivalent manner to the predicate devices and is safe and effective when used as intended. Design verification test reports are included in Section 18.
Biocompatibility information is consistent with the requirements of ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and Testing, and therefore the materials used in the manufacture of the Marrow Cellution Bone Marrow Aspiration Needle are suitable for their intended use. Biocompatibility information is included in Section 15.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Ranfac Corporation Mr. Christopher Whelan Senior Vice President 30 Doherty Avenue, P.O. Box 635 Avon, Massachusetts 02322
Re: K150563
Trade/Device Name: Marrow Cellution Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: March 4, 2015 Received: March 6, 2015
Dear Mr. Whelan:
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Traditional 510(k) - Marrow Cellution Bone Marrow Aspiration Needle
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement below. |
Indications for Use
| 510(k) Number ( if known ) | K150563 |
|---|---|
| Device Name | Marrow Cellution Bone Marrow Aspiration Needle |
| Indications for Use (Describe) | The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. |
| 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) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3681 (8/14)
:
- 1978 - 1994 - 1991 - 1991
Page 1 of 1
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PSC Poblishing Services (701) 443-6740 EF
3
510(k) Summary
The contents of this 510(k) summary on the following pages have been provided in conformance with 21 CFR PP 807.92 "content and format of a 510(k) summary".
1. Submitter/Sponsor
Ranfac Corp. 30 Doherty Avenue Avon, MA 02322 FDA Registration Number 1211566 Telephone Number/Fax: 508-588-4400 ext. 106/508-584-8588 Contact Person: Christopher P. Whelan Date Prepared: March 04, 2015
2. Device Name
Trade Name: Marrow Cellution Bone Marrow Aspiration Needle Common or Usual Name: Aspiration Needle Classification Name: Gastroenterology-Urology-Biopsy Instrument 21 CFR §876.1075, Product Code KNW Classification: Class II
3. Predicate Device:
| Trade Name | 510(k) | Company |
|---|---|---|
| Ranfac Aspiration Needle with Adjustable Guide | K140991 | Ranfac Corp. |
| Ranfac Bone Marrow Aspiration Needle | K131157 | Ranfac Corp. |
4. Device Description
The Marrow Cellution Bone Marrow Aspiration Needle consists of a Ranfac Aspiration Needle with Adjustable Guide as well as an additional Aspirator Cannula and a 10ml Syringe.
The Marrow Cellution Bone Marrow Aspiration Needle is a single use disposable needle that allows the medical device professional the ability to aspirate from the sides of the needle without aspirating from the needle tip. This allows the needle to be retracted during aspiration ensuring aspirate will not be compromised by the end being open to an area that has already had aspirate removed.
4
510(k) Summary
5. Indications For Use
The Marrow Cellution Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
Comparison of the Technological Characteristics With the Predicate Devices: 6.
As compared with the predicate devices, and as shown below, the Marrow Cellution Bone Marrow Aspiration Needle has the same indications for use, and has similar technological and operational characteristics when compared with the predicate devices.
Table 5.1 Comparison of the Proposed Marrow Cellution Bone Marrow Aspiration Needle to the Ranfac Aspiration Needle with Adjustable Guide and Ranfac Bone Marrow Aspiration Needle
| | Marrow Cellution Bone
Marrow Aspiration Needle
(This Submission) | Ranfac Aspiration Needle
with Adjustable Guide
(K140991) | Ranfac Bone Marrow
Aspiration Needle
(K131157) |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended Use | The Marrow Cellution Bone
Marrow Aspiration Needle is
intended for use for aspiration of
bone marrow or autologous blood
using a standard piston syringe. | The Ranfac Aspiration Needle
with Adjustable Guide is intended
for use for aspiration of bone
marrow or autologous blood using
a standard piston syringe. | The Ranfac Bone Marrow
Aspiration Needle is
intended for use in aspirating
bone marrow. |
| Design | Sterile, Disposable | Sterile, Disposable | Sterile, Disposable |
| Performance
Characteristics | Needle bores into bone to access
marrow cavity | Needle bores into bone to access
marrow cavity | Needle bores into bone to
access marrow cavity |
| Cannula
Configuration | Hollow Outer Cannula with cutting
edges without side ports
Hollow Inner Cannula with closed
end and side ports | Hollow Cannula with cutting
edges without side ports | Hollow Cannula with cutting
edges with or without side
ports |
| Stylet
Configuration | Trocar Tip and Blunt Tip | Trocar Tip and Blunt Tip | Trocar Tip |
| Ga. Size | 11Ga. | 11Ga. | 11Ga. & 8Ga. |
| Handle
Configuration | Handle is Molded to Cannula
Handle is Molded to Stylet | Handle is Molded to Cannula
Handle is Molded to Stylet | Handle is Molded to Cannula
Handle is Molded to Stylet |
| Materials:
Handles
Cannula/Stylet
Sterilization | ABS
AISI 304 Stainless Steel
(tested per ISO 9626)
Supplied Sterile
(Ethylene Oxide) | ABS
AISI 304 Stainless Steel
(tested per ISO 9626)
Supplied Sterile
(Ethylene Oxide) | ABS
AISI 304 Stainless Steel
(tested per ISO 9626)
Supplied Sterile
(Ethylene Oxide) |
5
510(k) Summary
7. Performance Data
Design verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the Marrow Cellution Bone Marrow Aspiration Needle performed in an equivalent manner to the predicate devices and is safe and effective when used as intended. Design verification test reports are included in Section 18.
Biocompatibility information is consistent with the requirements of ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and Testing, and therefore the materials used in the manufacture of the Marrow Cellution Bone Marrow Aspiration Needle are suitable for their intended use. Biocompatibility information is included in Section 15.
8. Clinical Data
Not applicable.
9. Conclusion
Based on the similarities in indications for use, materials, design, principles of function, biocompatibility and sterilization between the Marrow Cellution Bone Marrow Aspiration Needle, subject of this premarket notification, and the predicate devices, the proposed subject device has been shown to be substantially equivalent to the predicate devices in accordance with Section 510(k) of the Federal Food, Drug and Cosmetic Act.