(23 days)
The MALIS™ Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALIS™ generators.
The MALIS™ Irrigation Module 1000 is an irrigation control system for use with the MALIS™ CMC-III Bipolar Electrosurgical Systems and the Synergy MALIS™ Precision System. This system provides controlled flow of irrigating fluid across the tips of bipolar irrigating forceps.
The provided document is a 510(k) summary for the MALIS™ Irrigation Module 1000. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not available in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (MALIS™ Irrigation System K854413) in terms of: | The modified system, MALIS™ Irrigation Module 1000, is stated to be substantially equivalent to the predicate MALIS™ Irrigation System (K854413). |
| * Intended Use | Met (same as predicate) |
| * Function | Met (same as predicate) |
| * Technical Specifications | Met (same as predicate) |
| * Operating Principles | Met (same as predicate) |
| Verification and Validation Tests: | "All testing passed." (No specific criteria or results provided beyond this general statement) |
| * System Functionality | Passed |
| * Software Functionality | Passed |
| Electrical Safety Testing: | "All testing passed." (No specific criteria or results provided beyond this general statement) |
| * Electrical Safety Standards Compliance | Passed |
Missing Information:
- No specific, quantifiable acceptance criteria (e.g., specific flow rates, pressure ranges, electrical parameters, software response times) are provided. The "acceptance criteria" are broadly defined by substantial equivalence to the predicate device and general statements of "all testing passed."
- No quantitative device performance metrics are reported.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "Verification and validation tests" and "Electrical safety testing" but does not detail the number of units tested or the duration/extent of testing.
- Data Provenance: Not applicable in the context of clinical data for AI models. The testing described is for device functionality and safety, not performance on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This document describes a medical device for irrigation, not an AI or diagnostic imaging device that uses expert-established ground truth from medical images/cases. The "ground truth" here is implied by engineering specifications and safety standards.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of human-in-the-loop assessment or expert adjudication for the device's technical performance tests.
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 device is not an AI-powered diagnostic tool, and no MRMC study was performed or is relevant to this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The "software" component mentioned would likely refer to embedded control software, for which standalone performance testing (i.e., verifying the software correctly controls the device) would have been part of the verification and validation, but this is not an AI algorithm in the common sense.
7. The Type of Ground Truth Used:
- For device functionality and safety: The "ground truth" would be established engineering specifications, performance standards (e.g., related to flow, pressure, electrical safety), and regulatory compliance requirements. These are typically defined internally by the manufacturer and by relevant industry standards (e.g., IEC standards for electrical safety).
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this device. The device design and verification adhere to engineering principles and established performance specifications, not machine learning training.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
Summary of Device Acceptance and Study:
The MALIS™ Irrigation Module 1000 gained acceptance for marketing through the 510(k) pathway by demonstrating substantial equivalence to a previously cleared predicate device, the MALIS™ Irrigation System (K854413).
The "study" that proves the device meets acceptance criteria consists of:
- Verification and validation tests: These were conducted on the system and its software, and "all testing passed." The specific criteria for these tests were not detailed but would typically involve ensuring the device functions according to its design specifications regarding fluid flow, pressure, and control mechanisms.
- Electrical safety testing: Conducted to ensure compliance with relevant electrical safety standards, and "all testing passed."
The fundamental acceptance criterion for this 510(k) submission was that the new device, MALIS™ Irrigation Module 1000, is substantially equivalent to the predicate device (MALIS™ Irrigation System) in terms of its intended use, function, technical specifications, and operating principles. The safety and efficacy were substantiated by this similarity to the original device. No new clinical studies or detailed performance data comparing it to a standard of care were required or presented because the device was not deemed to represent a significant change in technological characteristics or indications for use.
{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, PresidentPhone Number: 610-666-7500Fax 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 andAccessories |
| Predicate Device: | MALISTM Irrigation System (K854413) |
| Intended Use: | The MALISTM Irrigation Module 1000 is indicated for use withirrigating bipolar forceps with the CODMAN® / MALISTMgenerators. |
| Device Description: | The MALISTM Irrigation Module 1000 is an irrigation controlsystem for use with the MALISTM CMC-III BipolarElectrosurgical Systems and the Synergy MALISTM PrecisionSystem. This system provides controlled flow of irrigating fluidacross the tips of bipolar irrigating forceps. |
| Performance Data: | Verification and validation tests were conducted on the on boththe system and its software. Electrical safety testing was alsoconducted. All testing passed. |
| Substantial Equivalence: | The modified system, the MALIS™ Irrigation Module 1000, issubstantially equivalent to the predicate MALISTM IrrigationSystem (K854413) in terms of intended use, function, technicalspecifications, and operating principles. The safety and efficacyof the MALIS™ Irrigation Module 1000 is thereforesubstantiated by its similarity to the original device, MALISTMIrrigation 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
§ 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.