(58 days)
Not Found
No
The summary describes a mechanical injection needle catheter and does not mention any software, algorithms, or data processing related to AI or ML.
Yes.
The device is used to introduce agents that control bleeding lesions and aid in endoscopic procedures, which are therapeutic interventions.
No
Explanation: The device is an injection needle catheter used to deliver therapeutic agents (sclerosing agents, vasoconstrictors, or saline) to control bleeding or aid in procedures like EMR and polypectomy. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly states the major components are a catheter, needle, and hub, 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 clearly describes a device used endoscopically to introduce substances into the digestive system for therapeutic purposes (controlling bleeding, aiding in procedures). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical device (catheter, needle, hub) designed for injection, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, 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 entirely therapeutic and procedural, not diagnostic.
N/A
Intended Use / Indications for Use
The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.
Product codes (comma separated list FDA assigned to the subject device)
78 FBK, 78 KOG, 78 FCG
Device Description
The Interject Injection Therapy Needle is an injection needle designed to be used with an endoscope to perform endoscopic injections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive system
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)
A biocompatibility assessment was performed on the patient- and fluid-contact materials of the predicate Interiect Injection Therapy Needle with satisfactory results. The proposed Interject device and predicate Interject device are identical therefore no additional biocompatibility was performed to include the new indication.
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
§ 876.1075 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
K012864
Page 1 of 2
SECTION 10 510(k) SUMMARY
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
Date:
Common/Usual Names: Trade/Proprietary Name: Classification Name & Device Classification:
Name Needle, Endoscope Endoscope & Accessories
Device Panel/Branch:
Owner/Operator:
August 21, 2001 needle, endoscope Interject™ Injection Therapy Needle
Class II
| Number | 21 CFR Ref |
|---|---|
| 78 FBK | 876.1500 |
| 78 KOG | 876.1500 |
Gastroenterology-Urology (GU) GASTRO-RENAL (GRBD)
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760
Contact Person:
James D. McMahon Regulatory Affairs Specialist
DESCRIPTION OF DEVICE
The Interject Injection Therapy Needle is an injection needle designed to be used with an endoscope to perform endoscopic injections.
INDICATIONS FOR USE
The Interject Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.
1
K012864
Page 2 of 2
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Interject™ Injection Therapy Needle with additional indications is substantially equivalent to the currently marketed Boston Scientific Corporation's Interject™ Therapy Needle, Variject™ Needle Catheter (K961846) and US Endoscopy Goup, Coaxial Needle (K971842). The major components of the devices are the catheter, needle, and hub. A thorough comparison of the descriptive characteristics between the proposed Interject device and the predicate device show equivalence.
PERFORMANCE CHARACTERISTICS
A biocompatibility assessment was performed on the patient- and fluid-contact materials of the predicate Interiect Injection Therapy Needle with satisfactory results. The proposed Interject device and predicate Interject device are identical therefore no additional biocompatibility was performed to include the new indication.
CONCLUSION
BSC has demonstrated that the Interject™ Injection Therapy Needle with additional indications is substantially equivalent to BSC's currently marketed Interiect Injection Therapy Needle, Variject Needle Catheter and US Endoscopy Group, Coaxial Needle,
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2001
Mr. James D. McMahon Regulatory Affairs Specialist Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
Re: K012864
Trade/Device Name: Interject™ Injection Therapy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: August 24, 2001
Dear Mr. McMahon:
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.
Received: August 27, 2001
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); 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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
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
SECTION 3 INDICATION FOR USE
510(k) Number:
To Be Determined K012864
Device Name:
Interject™ Injection Therapy Needle
Indication for Use:
The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding Scierosmy agent of vasoconserver and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.1091) | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
Nanare Shoodon
(Division Sten-Off)
Division of Reproductive, Abdonlinel,
and Redietegical Devices K012864
510(k) Number