(35 days)
Not Found
No
The summary describes a modification to existing bipolar forceps with a new coating and does not mention any AI/ML capabilities or data processing.
No
The device is used for tissue coagulation and cauterization during surgery, which are procedural steps to achieve hemostasis, not ongoing therapeutic treatment.
No.
The device is used for tissue coagulation and/or cauterization to achieve hemostasis during surgical procedures, which are therapeutic actions, not diagnostic.
No
The device description clearly states it is a physical medical device (forceps made of stainless steel or titanium) with a proprietary coating. It is not software.
No, 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, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that these Mirror Finish Bipolar Forceps are used during surgical procedures for tissue coagulation and cauterization to achieve hemostasis. This is a direct intervention on the body, not a test performed on a sample.
- Intended Use: The intended use is for surgical procedures in various specialties, not for diagnostic testing of samples.
The device is a surgical instrument used for therapeutic purposes (stopping bleeding), not for diagnostic purposes (analyzing samples to determine a medical condition).
N/A
Intended Use / Indications for Use
These Mirror Finish Bipolar Forceps are indicated for use in any surgical procedure that requires tissue coagulation and/or cauterization to achieve hemostasis. They are indicated for use in:
-
- general surgery,
-
- neurosurgery,
-
- urology, and nephrology.
Product codes
79 GEI
Device Description
The JJPI Bipolar Forceps Line is a modification of the bipolar forceps we currently have on the market. These forceps are made of either stainless steel or titanium. The only difference between our currently marketed line of bipolar forceps and the new line under consideration is the mirror finish proprietary coating that is applied to the tips.
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
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the JJPI Mirror Finish Bipolar Forceps is substantiated by similarity in its intended use and function to the JJPI Bipolar Forceps Line and the KIR WAN Non-Stick Bipolar Forceps. The functional testing and the basic mechanical properties exhibited by the JJPI non-stick forceps indicate that the JJPI proprietary coated tips are functionally equivalent to both the JJPI Bipolar Forceps Line and the KIRWAN Non-Stick Bipolar Forceps.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Summary of Safety & Effectiveness Data for the Mirror Finish Bipolar Forceps Line
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350 OCT - 8 1996
1. Contact Person
Jennifer Morse, Assoc. Regulatory Affairs Specialist, (508) 880-8417.
2. Device Name
| Proprietary Name: | Mirror Finish Bipolar Forceps |
|---|---|
| Common Name: | Bipolar Forceps |
| Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Regulatory Class: | Class II by 21 CFR § 878.4400 |
| Product Code: | 79 GEI |
| Owner/ Operator # | 9001269 |
3. Device Classification
Classification for bipolar forceps has been placed in Class II by 21 CFR § 878.4400
4. Statement of Substantial Equivalence
The safety and effectiveness of the JJPI Mirror Finish Bipolar Forceps is substantiated by similarity in its intended use and function to the JJPI Bipolar Forceps Line and the KIR WAN Non-Stick Bipolar Forceps. The functional testing and the basic mechanical properties exhibited by the JJPI non-stick forceps indicate that the JJPI proprietary coated tips are functionally equivalent to both the JJPI Bipolar Forceps Line and the KIRWAN Non-Stick Bipolar Forceps.
5. Indications for Use
These Mirror Finish Bipolar Forceps are indicated for use in any surgical procedure that requires tissue coagulation and/or cauterization to achieve hemostasis. They are indicated for use in:
-
- general surgery,
-
- neurosurgery,
-
- urology, and nephrology.
1
6. Physical Description
The JJPI Bipolar Forceps Line is a modification of the bipolar forceps we currently have on the market. These forceps are made of either stainless steel or titanium. The only difference between our currently marketed line of bipolar forceps and the new line under consideration is the mirror finish proprietary coating that is applied to the tips.
Similarities and Differences Matrix
| | JJPI Mirror Finish
Bipolar Forceps | JJPI Bipolar Forceps
Line | Kirwan Non-Stick
Bipolar Forceps |
|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------|-------------------------------------|
| Features | | | |
| DESIGN | | | |
| Tips highly polished | Yes | Yes | Yes |
| Non-Stick qualities | Yes | Yes | Yes |
| Tip size | 0.25 mm - 2 mm | 0.25 mm. - 2 mm | 0.5 mm. - 2 mm |
| Forceps Shape | Bayonet and straight | Bayonet and straight | Bayonet and straight |
| Reusable | Yes | Yes | Yes |
| INTENDED USE | | | |
| Indicated for use in any surgical
procedure which requires tissue
coagulation and/or cauterization
to achieve hemostasis. | Yes | Yes | Yes |
| They are indicated for use in:
- general surgery, | | | |
| 2. neurosurgery, | Yes | Yes | Yes |
| 3. urology, and nephrology. | | | |
| MATERIALS | | | |
| Nickel | No | No | No |
| Stainless Steel, Titanium | Yes | Yes | No |