(42 days)
Not Found
No
The device description and intended use clearly describe a mechanical injection needle accessory for endoscopes, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is described as an accessory for endoscopes that delivers injectable materials. It does not exert its own therapeutic action but rather facilitates the delivery of substances that may have a therapeutic effect.
No
Explanation: The device is an injection needle designed to deliver materials into tissue during an endoscopic procedure, not to diagnose a condition. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly states it is a physical needle and insertion tube made of stainless steel and plastic, which are 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 to deliver injectable materials into tissue during an endoscopic procedure. This is an in vivo application (within a living organism).
- Device Description: The device is a needle designed for injection into tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly administer substances into the body.
N/A
Intended Use / Indications for Use
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
Product codes
78 FBK
Device Description
The Carbon Medical Technologies Endoscopic Injection Needle consists of a stainless steel needle attached to a plastic insertion tube. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the proximal end of the device, is designed to accommodate a standard syringe.
The CMT Endoscopic Injection Needle is provided sterile and is intended for single use only.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
| 510(k) SUMMARY | NOV - 5 2004 | K042615 |
|---|---|---|
| General Information | PG: 1 OF 2 | |
| Date Prepared | September 22, 2004 | |
| Classification | Class II | |
| Trade Name | Carbon Medical Technologies Endoscopic Injection Needle | |
| Common Name | Endoscopic Needle | |
| Submitter | Carbon Medical Technologies, Inc. | |
| 1290 Hammond Road | ||
| St. Paul, MN 55110 | ||
| 651-653-8512 | ||
| Contact | Robert W. Johnson | |
| Vice President of Regulatory Affairs and Quality Assurance | ||
| Predicate Device | Scerotherapy Needle | |
| Medi-Glove (K955558) | ||
| CMT Endoscopic Injection Needle | ||
| Carbon Medical Technologies, Inc. (K982890) |
.
·
1
Device Description
The Carbon Medical Technologies Endoscopic Injection Needle consists of a stainless steel needle attached to a plastic insertion tube. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the proximal end of the device, is designed to accommodate a standard syringe.
The CMT Endoscopic Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of injectable bulking agent during endoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures.
The CMT Endoscopic Injection Needle is provided sterile and is intended for single use only.
Indication
The CMT Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
Technological Characteristics
The CMT Injection Needle consists of a stainless steel needle attached to a plastic cannula. A plastic luer lock hub is molded onto the proximal end where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue. Multiple needle lengths are available to accommodate the length of the endoscope channel.
Summary
In summary, CMT believes the above listed predicate devices and the CMT Needle are substantially equivalent based on design, materials, methods of fabrication and indications for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle. The eagle is facing to the right and has three lines that represent its wings.
NOV - 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert W. Johnson Vice President, Regulatory and Clinical Affairs and Ouality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road ST PAUL MN 55110-5867
Re: K042615
Trade/Device Name: Carbon Medical Technologies Endoscopic Injection Needle Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FBK Dated: September 22, 2004 Received: September 24, 2004
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have it wear your bection by equivalent (for the indications for use stated in above and nave determined and onedicate devices marketed in interstate commerce prior to the cherosate) to regally mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the onlinement the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that ICclassified in accordanted with the per al application (PMA). You may, therefore, market the do not require approval of a provisions of the Act. The general controls provisions of the Act de nec, subject to the general estistion, 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 (Premarket it your de riot is elabories (300 acch additional controls. Existing major regulations affecting your Apployal), It thay be subject to racin aderal 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 I lease be advised that i 27 i in 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 I cation statues and regulations as amontimited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, mending out noing practice requirements as set forth in the quality systems (QS) (21 CFR Part 807), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmam.html
Sincerely vours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K042615
Carbon Medical Technologies Endoscopic Injection Needle Device Name:
Indications For Use:
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
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproduc and Radiological Devi 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________