(23 days)
Not Found
No
The summary describes a fluid control system for irrigating bipolar forceps and does not mention any AI or ML capabilities.
No
The device is an irrigation control system that provides controlled flow of irrigating fluid. It is part of an electrosurgical system but does not directly provide therapy.
No
This device is described as an "irrigation control system" that provides "controlled flow of irrigating fluid" for use with electrosurgical systems and bipolar forceps. Its function is to facilitate irrigation during surgical procedures, not to diagnose medical conditions by identifying diseases, conditions, or injuries.
No
The device description explicitly states it is an "irrigation control system" and mentions "controlled flow of irrigating fluid," indicating a hardware component responsible for fluid delivery and control. The performance studies also mention "system and its software" and "electrical safety testing," further suggesting a hardware component.
Based on the provided information, the MALIS™ Irrigation Module 1000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide controlled flow of irrigating fluid across the tips of bipolar irrigating forceps during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on samples like blood or tissue).
- Device Description: The description confirms its use as an irrigation control system for electrosurgical systems, which are used directly on patients during surgery.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any other activities typically associated with IVD devices.
Therefore, the MALIS™ Irrigation Module 1000 is a surgical device used during procedures on a patient, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The MALISTM Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALISTM generators.
Product codes
GEI
Device Description
The MALISTM Irrigation Module 1000 is an irrigation control system for use with the MALISTM CMC-III Bipolar Electrosurgical Systems and the Synergy MALISTM Precision System. This system provides controlled flow of irrigating fluid across the tips of bipolar irrigating forceps.
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
Verification and validation tests were conducted on the on both the system and its software. Electrical safety testing was also conducted. All testing passed.
Key Metrics
Not Found
Predicate Device(s)
MALISTM Irrigation System (K854413)
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
NOV 2 8 2003
510(k) Summary for the MALIS™ Irrigation Module 1000
K 0 33 4 99
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: | 10/30/03 |
| Proprietary Name: | MALISTM Irrigation Module 1000 |
| Common Name: | Irrigation Device for Bipolar Coagulation and Cutting |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessory |
| Device Classification: | This device is Class II per Class II per 21 CFR § 878.4400 -
Electrosurgical Cutting and Coagulation Device and
Accessories |
| Predicate Device: | MALISTM Irrigation System (K854413) |
| Intended Use: | The MALISTM Irrigation Module 1000 is indicated for use with
irrigating bipolar forceps with the CODMAN® / MALISTM
generators. |
| Device Description: | The MALISTM Irrigation Module 1000 is an irrigation control
system for use with the MALISTM CMC-III Bipolar
Electrosurgical Systems and the Synergy MALISTM Precision
System. This system provides controlled flow of irrigating fluid
across the tips of bipolar irrigating forceps. |
| Performance Data: | Verification and validation tests were conducted on the on both
the system and its software. Electrical safety testing was also
conducted. All testing passed. |
| Substantial Equivalence: | The modified system, the MALIS™ Irrigation Module 1000, is
substantially equivalent to the predicate MALISTM Irrigation
System (K854413) in terms of intended use, function, technical
specifications, and operating principles. The safety and efficacy
of the MALIS™ Irrigation Module 1000 is therefore
substantiated by its similarity to the original device, MALISTM
Irrigation System (K854413). |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The profiles are silhouetted and appear to be stacked or layered.
NOV 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerry L. Malis President Valley Forge Scientific Corporation 136 Green Tree Road, Suite 100 P.O. Box 1179 Oaks, Pennsylvania 19456
Re: K033499
Trade/Device Name: MALIS™ Irrigation Module 1000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 3, 2003 Received: November 6, 2003
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 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.
2
Page 2 - Mr. Jerry L. Malis
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark N. Milken
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
3
K033499 510(k) Number (if known):
Device Name MALISTM Irrigation Module 1000
Indications for Use
The MALIS™ Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALIS™ generators.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: \checkmark OR Over-The-Counter Use: __
(Per 21 CFR 801.109)
for Mark n Melken
Division Sign-Off!
Division of General, Restorative
Neurological Devices
:) Number __ K033499