(208 days)
Not Found
No
The description focuses on the mechanical components and function of a needle for marker delivery, with no mention of AI or ML.
No.
The device facilitates the delivery of fiducial markers for imaging, but it does not directly treat a disease or condition. Its function is diagnostic or procedural preparation rather than therapeutic intervention.
No
The device is described as a needle for delivering fiducial markers into soft tissue. There is no mention of it collecting or analyzing data for diagnostic purposes. Its function is interventional (delivery), not diagnostic.
No
The device description clearly outlines physical components (outer cannula, inner stylet, depth stop) and its function involves the physical delivery of fiducial markers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allow delivery of fiducial markers into soft tissue." This is a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a needle used for insertion into tissue. This is a surgical or interventional device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for delivering a physical object (fiducial markers) into tissue.
N/A
Intended Use / Indications for Use
The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
FBK, NEU
Device Description
The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop.
The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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): 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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Page 1 of 2
510(k) Summary 5
5. 510(k) Summary
5 -
ं . . .
Andrew Adams Director - Regulatory Affairs & Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110
651-653-8512 Phone: Fax: 651-407-1975
Submitted: September 27, 2013
Device Name
| Trade Name: | BiomarC Coaxial Needle |
|---|---|
| Classification Name: | Endoscopic Injection Needle, 21 CFR 876.1500, FBK |
| Implantable Clip, 21 CFR 878.4300, NEU | |
| Common/Usual Name: | Coaxial Needle |
Predicate Devices
Carbon Medical Technologies Endoscopic Injection Needle (K042615), by Carbon Medical Technologies, Inc. Coaxial Biopsy Needle (K936194), by Bard Gynecology & Radiology
Indication for Use
The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.
Device Description
The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop.
The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.
BiomarC Coaxial Needle Premarket Notification 510(k) 5-1 (May 8, 2014)
MAY 1 3 2014
1
Technological Characteristics and Performance
ﺎ
The technological characteristics and performance of the BiomarC Coaxial Needle are substantially equivalent to the predicate devices (Table 5).
| Characteristic | Proposed Device | Predicate Device | Predicate Device |
|---|---|---|---|
| Trade name | BiomarC Coaxial Needle | Carbon Medical | |
| Technologies Endoscopic | |||
| Injection Needle | Coaxial Biopsy Needle | ||
| 510(k) number | K042615 | K936194 | |
| 510(k) holder | Carbon Medical | ||
| Technologies, Inc. | Carbon Medical | ||
| Technologies, Inc. | Bard Gynecology and | ||
| Radiology | |||
| Indications for | |||
| use | The BiomarC Coaxial | ||
| Needle allows delivery of | |||
| fiducial markers into soft | |||
| tissue. | The Carbon Medical | ||
| Technologies Injection | |||
| Needle is an accessory for | |||
| currently marketed | |||
| endoscopes to allow | |||
| delivery of injectable | |||
| materials into tissue during | |||
| an endoscopic procedure. | The coaxial biopsy needle | ||
| guide is intended for use as | |||
| a guiding needle in | |||
| obtaining core, biopsy | |||
| samples from soft tissue | |||
| such as liver, kidney, | |||
| spleen, lymph nodes and | |||
| various soft tissue lesions. | |||
| Use | Single use | Single use | Single use |
| Sterility | Sterilized by EO with an | ||
| SAL of 1x10-6 | Sterilized by EO with an | ||
| SAL of 1x10-6 | Sterilized by EO | ||
| Pyrogens | Pyrogen free | Pyrogen free | Pyrogen free |
| Cannula/stylet | |||
| rod material | Stainless steel, type 304 | Stainless steel | Stainless steel |
| Tip style | Trocar tip | Spinal tip | Trocar or blunt tip |
| Device body | |||
| contact | |||
| category | External communicating | ||
| device, tissue, limited | External communicating | ||
| device, tissue, limited | External communicating | ||
| device, tissue, limited | |||
| Safety | Safety has been established | ||
| for the identical nature and | |||
| duration of patient contact | |||
| through a history of use in | |||
| other similar devices. | Safety has been established | ||
| for the identical nature and | |||
| duration of patient contact | |||
| through a history of use in | |||
| other identical and similar | |||
| devices. | Unknown | ||
| Able to create a channel | |||
| through soft tissue | Able to create a channel | ||
| through soft tissue | Able to create a channel | ||
| through soft tissue | |||
| Performance | Able to allow delivery of | ||
| fiducial markers through | |||
| channel created | Able to allow delivery of | ||
| injectable materials through | |||
| channel created | Able to guide another | ||
| device through channel | |||
| created |
BiomarC Coaxial Needle Premarket Notification 510(k) 5-2 (May 8, 2014)
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2014
Carbon Medical Technologies Incorporated Mr. Andrew J. Adams Director, Regulatory Affairs & Quality Assurance 1290 Hammond Road Saint Paul, Minnesota 55110
Re: K133148
Trade/Device Name: BiomarC Coaxial Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK, NEU Dated: March 6, 2014 Received: March 7, 2014
Dear Mr. Adams:
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 - Mr. Andrew J. Adams
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for . Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications for Use Statement
510(k) Number: K133148
Device Name: BiomarC Coaxial Needle
Indications for Use:
The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
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BiomarC Coaxial Needle Premarket Notification 510(k) 4-1 (May 8, 2014)