(100 days)
Not Found
No
The device description focuses on mechanical and electrical components for injection, electrohemostasis, and irrigation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is indicated for endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract, which are therapeutic interventions.
No
The device is used for therapeutic purposes (endoscopic injection therapy and electrohemostasis) to treat bleeding sites, not to identify or diagnose conditions.
No
The device description clearly outlines a physical catheter with a needle, electrodes, and irrigation capabilities. It is a hardware device used for injection and electrohemostasis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Injection Gold Probe Bipolar Electrohemostasis Catheter is used inside the body (in the gastrointestinal tract) for direct intervention (injection therapy and electrohemostasis) on bleeding sites. It is a therapeutic device, not a diagnostic one that analyzes samples.
The description clearly outlines its use for treating bleeding within the GI tract, which is an in-vivo (within the living organism) procedure, not an in-vitro one.
N/A
Intended Use / Indications for Use
The Injection Gold ProbeTM Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
- Peptic Ulcers
- Dieulafoy Lesions
- Mallory-Weiss Tears
- Bleeding Polyp Stalks
- Arteriovenous Malformations (AVMs)
- Angiomata
The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The Injection Gold Probe Catheter is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe Catheter is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the Mediglide coating on the catheter promotes minimal friction during endoscope passage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
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)
Biocompatibility Testing has been performed to demonstrate that the material changes made to the proposed device are biocompatible.
Bench Testing has been performed on the proposed Injection Gold ProbeTM Bipolar Electrohemostasis Cather to demonstrate that the modified device meets the required specifications of the completed tests. The following bench tests were performed:
- Combination Therapy Device
- Device Irrigation Flow Rate
- Injection Needle Flow Rate
- Injection Needle Extension and Retraction
- Injection Needle Retraction Lock
- Injection Hub to 22-gauge Hypotube Joint Tensile Strength
- 25-gauge Injection Needle to the 22-Gauge Hypotube Joint Tensile Strength
- Needle Specification
All biocompatibility tests conducted on the proposed Injection Gold ProbeTM Bipolar Electrohemostasis Catheter passed. Therefore, the Injection Gold ProbeTM Bipolar Electrohemostasis Catheter is considered biocompatible.
All device bench tests results were acceptable. The data demonstrate that the Injection Gold ProbeTM Bipolar Electrohemostasis Catheter meets design specifications and is suitable for its intended use.
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
APR 0 2 2014
K133933 Page 1 of 3
SECTION 6 510(k) SUMMARY
00000.9.5
510(k) SUMMARY
1, Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Ashley Pyle Regulatory Affairs Manager Telephone: 508-683-4359 Fax: 508-683-5939
Secondary Contact: Jennifer Kimball Director of Regulatory Affairs Telephone: 508-683-4178 Fax: 508-683-5939
Date Prepared: December 20, 2013
2. Proposed Device:
Trade Name: Injection Gold ProbeTM Bipolar Electrohemostasis Catheter Classification Name: Unit, Electrosurgical, Endoscopic (with accessories) Regulation Number: 876.4300 Product Code: KNS Classification: Class II
3. Predicate Device:
Trade Name: Injection Gold ProbeTM Binolar Electrohemostasis Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K 110887 Classification Name: Unit, Electrosurgical, Endoscopic (with accessories) Regulation Number: 876.4300 Product Codc: KNS Classification: Class II
4. Proposed Device Description:
The Injection Gold Probe Catheter is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe Catheter is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for persendicular and tangential use, while the Mediglide coating on the catheter promotes minimal friction during endoscope passage.
Special 510(k) Premarket Notification, Injection Gold ProbeTM Bipolar Electrohemostasis Catheter
1
-
I. Injection Therapy
Each Injection Gold Probe Catheter contains a 25 gauge injection needle for injection therapy. The catheter handle contains the injection needle hub. Injection is performed by attaching a luerlock syringe to the "Injection" hub and advancing the needle. -
II. Bipolar Electrohemostasis
The gold-spiral electrode on the probe tip provides bipolar electrohemostasis. The Injection Gold Probe Catheter connects directly to the Endostat™ family of Bipolar Electrosurgical Generators. Or utilize the Bipolar Cable Adapter supplied by Boston Scientific for other bipolar electrosurgical generators. -
III. Irrigation
Irrigation with saline or sterile water is performed by connecting the irrigation hub to the irrigation port of the bipolar generator or to a 30 cm3 (30 cc) or 60 cm3 (60 cc) luer-lock syringe or mechanical irrigation system for generators without irrigation capability.
5. Intended Use/Indications for Use:
The Injection Gold ProbeTM Bipolar Electronemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
- Peptic Ulcers �
- o Dieulafoy Lesions
- o Mallory-Weiss Tears
- 0 Bleeding Polyp Stalks
- Arteriovenous Malformations (AVMs) o
- Angiomata �
The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended.
6. Description of Change for this Submission:
The following changes are being made to the proposed Injection Gold Probe Bipolar Electrohemostasis Catheter:
- The current PTF : coating on the Injection Cold Probe (IGP) Needle Hub to Hypotube � Assemblies, is changing to a slightly modified PTFE coating.
- The current chemical weld used to attach the hypotube to injection hub, is being replaced o with an adhesive bond.
7. Technological Characteristics:
The proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter has the same fundamental design, operating principal and intended use as the predicate Injection Gold Probe™ Binolar Electrohemostasis Catheter (K110887). The proposed device has material differences when compared to the currently marketed Injection Gold Probe™ Bipolar Electrohemostasis Catheter (K110887).
8, Performance Data:
Biocompatibility Testing has been performed to demonstrate that the material changes made to the proposed device are biocompatible.
0000116
Special 510(k) Premarket Notification, Injection Gold Probe131 Bijolar Electrohemostasis Catheter
2
Bench Testing has been performed on the proposed Injection Gold ProbeTM Bipolar Electrohemostasis Cather to demonstrate that the modified device meets the required specifications of the completed tests. The following bench tests were performed:
- o Combination Therapy Device
- o Device Irrigation Flow Rate
- 0 Injection Needle Flow Rate
- o Injection Needle Extension and Retraction
- Injection Needle Retraction Lock 0
- o Injection Hub to 22-gauge Hypotube Joint Tensile Strength
- 25-gauge Injection Needle to the 22-Gauge Hypotube Joint Tensile Strength 0
- o Needle Specification
9. Conclusion:
All biocompatibility tests conducted on the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter passed. Therefore, the Injection Gold ProbeTM Bipolar Electrohemostasis Catheter is considered biocompatible.
All device bench tests results were acceptable. The data demonstrate that the Injection Gold Probetal Bipolar Electrohemostasis Catheter meets design specifications and is suitable for its intended use.
Boston Scientific Corporation has demonstrated that the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed Injection Gold Probe™ Bipolar Electrohemostasis (K110887).
000017
Special 510(k) Premarket Notification, Injection Cold Probe131 Bipolar Electrohemostasis Catheter
3
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2014
Boston Scientific Corporation Ashley Santos Regulatory Affairs Manager 100 Boston Scientific Way Marlborough, MA 01752
Re: K133933
Trade/Device Name: Injection Gold Probe™ Bipolar Electrohemostasis Catheter Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: February 28, 2014 Received: March 4, 2014
Dear Ashley Santos,
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 connine. 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). and Cosmetic Act (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, therefore, mans 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 addition: "Fease note: "Obter ver, 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 If your device is elaboried (controls. Existing major regulations affecting your device can be may be subject to additions, 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 Please oe advised that I Dri 3 issuance of a sudenine complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies.
4
Page 2 - Ashley Santos
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher -S". The words are written in a bold, sans-serif font. The letters "DA" are stylized with a geometric pattern. The text is black against a white background.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications For Use:
To Be Determined K133933
Injection Gold ProbeTB1 Bipolar Electrohemostasis Catheter
The Injection Gold ProbeTM Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or notential bleeding sites in the gastrointestinal tract. These sites include the following:
- Peptic Ulcers �
- ◆ Dieulafoy Lesions
- Mallory-Weiss Tears .
- Bleeding Polyp Stalks ●
- Arteriovenous Malformations (AVMs) .
- Angiomata ●
The Injection Gold Probe Bipolar Blectrohemostasis Catheter also has irrigation capability. Any other use is not recommended.
Prescription Use X (Part 21 CPR 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 NBEDED)
Concurrence of CDRH, Office of Device Bvaluation (ODB)
Beniami 2014.04. 8 -04'00'
00014
Special 510(k) Premarket Nollfication, Injection Gold Probota Electrohenrostasis Catheter