(28 days)
Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessories: Hand Officening vising high frequency (RF) current.
Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.
This document is a 510(k) summary for a medical device called the "Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pens". It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way that would be expected for a diagnostic AI device.
Therefore, many of the requested categories are not applicable to the provided text.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics from a study. The document focuses on substantial equivalence to predicate devices and adherence to general controls for medical devices.
- Reported Device Performance: Not reported in terms of specific performance metrics from a study as this is not a diagnostic device with performance claims like sensitivity or specificity. The key performance aspect highlighted is the bipolar technology, which "eliminates the electrical current being passed through the patient and the use of grounding pads and their inherent safety hazards" and "permits the surgeon to work in a wet or irrigated surgical field without current shunting." These are functional benefits rather than quantitative "performance" in the context of device accuracy.
| Acceptance Criteria (Inferred from Substantial Equivalence and Safety) | Reported Device Performance (Operational Benefits/Differences) |
|---|---|
| Safety: Eliminates hazards associated with grounding pads. | The bipolar method eliminates the electrical current being passed through the patient and the use of grounding pads and their inherent safety hazards. |
| Functionality in surgical field: Operable in wet/irrigated conditions without current shunting. | Bipolar technology also permits the surgeon to work in a wet or irrigated surgical field without current shunting. |
| Physical Construction: Similar to predicate devices. | The physical construction of both the mono-polar and bipolar instruments are essentially identical. The switch mechanisms on both are liquid sealed with buttons molded in place. |
| Intended Use: Consistent with predicate devices. | Indicated for use with the Valley Forge Scientific 300 Bipolar System. Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessories: Hand-Switching Pen for cutting and coagulating tissue using high frequency (RF) current. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for an electro-surgical instrument, which is typically cleared through substantial equivalence based on engineering specifications, biocompatibility, electrical safety testing (ISO standards), and comparison to existing predicate devices, rather than a clinical trial with a "test set" in the context of diagnostic performance. There is no mention of a clinical study or a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As there is no clinical "test set" or diagnostic ground truth to be established, no experts were utilized in this manner for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware electro-surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Given the nature of the device (electro-surgical instrument), the "ground truth" for its safety and effectiveness would come from engineering testing, adherence to recognized standards (though none are mandated for this specific device per the document), and demonstration of substantial equivalence in form and function to legally marketed predicate devices. No formal "ground truth" as you'd find in a diagnostic study is mentioned.
8. The sample size for the training set
- Not Applicable. There is no mention of a training set as this is not a learning algorithm or a device requiring data training.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
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510(k) Summarv for the Malis Bipolar Disposable Electro-Surgical Pens
OCT 2 2 2004
Valley Forge Scientific Corp. 136 Green Tree Rd., Suite 100, P. O. Box 1179 Oaks, PA 19456
| Contact Person: | Jerry L. Malis, President |
|---|---|
| Phone Number: | 610-666-7500 |
| Fax Number: | 610-666-7565 |
| Date Prepared: | September 21, 2004 |
|---|---|
| Proprietary Name: | Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pens |
| Common Name: | Bipolar Disposable Electro-Surgical Pens |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessory |
| Device Classification: | This device is Class II per CFR § 878.4400- |
Electrosurgical Cutting and Coagulation Instruments
Predicate Devices:
| K910510 | Valley Forge Scientific Corp. | K896626 | Conmed Corp. |
|---|---|---|---|
| K955764 | Valley Forge Scientific Corp. | K982742 | New Deantronics |
| K973554 | Valley Forge Scientific Corp. | K982884 | New Deantronics |
| K932345 | Conmed Corp. | K850297 | Birtcher Corp. |
Intended Use: The Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pen is indicated for use with the Valley Forge Scientific 300 Bipolar System.
Device Description: Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.
Performance Standards: Pursuant to Section 514 of the FD&C Act and 21 CFR 888, no performance standards have been established for this device
Substantial Equivalence:
The Valley Forge Scientific Malis bipolar instruments are similar in use to Bovietype mono-polar instruments which have been marketed for the past 25-30 years (prior to May 28, 1976). Both the mono-polar and the bipolar instruments depend on an electro-surgical generator to deliver RF current to the tips of the instruments for cutting and coagulation.
The difference between the two methods can be found in the fact that with the mono-polar systems, the current passes from an active electrode through the patient to a grounding pad. The bipolar method eliminates the electrical current being passed through the patient and the use of grounding pads and their inherent safety hazards. Bipolar technology also permits the surgeon to work in a wet or irrigated surgical field without current shunting.
The physical construction of both the mono-polar and bipolar instruments are essentially identical. The switch mechanisms on both are liquid sealed with buttons molded in place.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
Mr. Jerry L. Malis President and CEO Valley Forge Scientific Corporation 136 Green Tree Road, Suite 100 P.O. Box 1179 Oaks, Pennsylvania 19456
Re: K042604
Trade/Device Name: Valley Forge Scientific MALIS™ Bipolar Disposable Hand-Switching Electro-Surgical Pencil, Loops, and Ball Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 21, 2004 Received: September 24, 2004
Dear Mr. Malis:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Jerry L. Malis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier with anow you to ough maine of substantial equivalence of your device to a legally prematicated predicated. The 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 11 you desire specific acries at (240) 276-0115. Also, please note the regulation entitled, Connact the Office of Coach to premarket notification" (21CFR Part 807.97). You may obtain Whisolaining of Yererence to premessionsibilities under the Act from the Division of Small other general mionnation 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name
Valley Forge Scientific MALIS ™ Bipolar Disposable Hand-Switching Electro-Surgical Pencils, Loops, and Ball.
Indications for Use
Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessones: Hand Officening vising high frequency (RF) current.
| Prescription Use:(Per 21 CFR 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 needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K042604
§ 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.