(406 days)
The Modulap Loop is intended for monopolar electrosurgical coagulation/cutting during laparoscopic surgery. It is indicated for the amputation of the uterus during supracervical hysterectomy and for resection of pedunculated subserosal (abdominal) myomas.
It is not intended for use in hysteroscopy or for contraceptive coagulation of the fallopian tubes.
The Modulap Loop is a 5 mm laparoscopic instrument. It consists of a standard insulated monopolar electrosurgical probe, with a flexible wire loop as its distal tip, and a sliding sheath constructed of insulating material. The wire loop is insulated except for a central approximately 1 inch cutting area. The device is a single-use sterile, disposable device. It is compatible with standard electrosurgical generators, and associated cables.
The provided text is related to a 510(k) submission for a medical device called "Modulap Loop." A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific acceptance criteria and proving performance against them in the way a clinical study for a novel device would.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and especially MRMC effectiveness or standalone algorithm performance, is not present in the provided document. This document describes a traditional medical device (unipolar endoscopic coagulator-cutter) and its 510(k) summary for regulatory clearance, not an AI/ML powered device.
However, I can extract what is provided regarding performance testing and the basis for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the typical format you might see for an AI/ML performance study. Instead, it states that various types of testing were performed to support equivalence to the predicate device.
| Acceptance Criteria Category (Implied for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Performance Testing | "Testing including performance... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Reliability Testing | "Testing including... reliability... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Materials Property Testing | "Testing including... materials property testing... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Biocompatibility Testing | "Testing including... biocompatibility... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Packaging Validation | "Testing including... packaging validation... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Electrical Safety Testing | "Testing including... electrical safety testing... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Technological Characteristics Equivalence | "The Modulap Loop and the Predicate device (Lina Gold Loop, K070315) are both Monopolar electrosurgical electrode with loop style tip and sliding sheath; sized to pass through 5 mm laparoscopic trocar; and compatible with standard electrosurgical generators. Their indications for use are equivalent, and other technological characteristics such as design, materials, performance, anatomical sites, energy used, human factors, biocompatibility, sterility, electrical safety, mechanical safety and standards met are the same or equivalent." |
| Intended Use Equivalence | "Their indications for use are equivalent." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this is a physical medical device and a 510(k) submission, the "test set" would refer to the number of devices or components tested, and the "data provenance" would refer to where manufacturing and testing took place, if applicable. This level of detail about the testing protocol is not included in this summary.
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)
This information is not applicable as the document describes a physical surgical device, not an AI/ML algorithm that requires expert consensus for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
An MRMC study is not applicable as this is a physical surgical device, not an AI/ML algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical surgical device, not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/ML ground truth definition. For a physical device, testing typically involves engineering measurements, material analysis, and potentially in-vitro or in-vivo (animal or human clinical) studies to confirm performance against established standards or predicate device performance. The document only generically states "performance, reliability, materials property testing, biocompatibility, packaging validation and electrical safety testing."
8. The sample size for the training set
This information is not applicable as this is a physical surgical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
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5. 510(k) Summary
| Date Prepared: | March 15, 2012 JUN 1 4 2013 |
|---|---|
| Device Trade Name: | Modulap Loop |
| Common Name: | Unipolar endoscopic coagulator-cutter |
| Submitter: | ATC Technologies Inc.30B Upton Drive,Wilmington, MA 01887 |
| Contact Person: | John Gillespie (consultant)Phone: (774) 567-0277Fax Number: (781) 939-0726Email: jgillespie@clovermedical.com |
| Classification: | Coagulator-Cutter, Endoscopic, Unipolar (andaccessories) 21 CFR 884.4160, Product code KNF,Class II |
| Intended Use: | The Modulap Loop is intended for the amputation ofthe uterus during laparoscopic supracervicalhysterectomy and for resection of pedunculatedsubserosal (abdominal) myomas.It is not intended for use in hysteroscopy or forcontraceptive coagulation of the fallopian tubes. |
Description of Device
The Modulap Loop is a 5 mm laparoscopic instrument. It consists of a standard insulated monopolar electrosurgical probe, with a flexible wire loop as its distal tip, and a sliding sheath constructed of insulating material. The wire loop is insulated except for a central approximately 1 inch cutting area. The device is a single-use sterile, disposable device. It is compatible with standard electrosurgical generators, and associated cables.
Summary of Technological Characteristics vs. Predicate
The Modulap Loop and the Predicate device (Lina Gold Loop, K070315) are both Monopolar electrosurgical electrode with loop style tip and sliding sheath; sized to pass through 5 mm laparoscopic trocar; and compatible with standard electrosurgical generators. Their indications for use are equivalent, and other technological characteristics such as design, materials, performance, anatomical sites, energy used, human factors, biocompatibility, sterility, electrical safety, mechanical safety and standards met are the same or equivalent.
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Test Data
Testing including performance, reliability, materials property testing, biocompatibility, packaging validation and electrical safety testing was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness.
Substantial Equivalence
Based on the Indication for Use, technological characteristics, performance testing, and comparison to its predicate device we conclude that the Modulap Loop has been shown to be substantially equivalent to a legally marketed predicate device and is safe and effective for its intended use.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
ATC Technologies, Inc. % Mr. John Gillespie Consultant Clover Medical 79 Haven Street DOVER MA 02030
Re: K121343
Trade/Device Name: Modulap Loop Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: KNF Dated: May 17, 2013 Received: June 7, 2013
Dear Mr. Gillespie:
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,-1.976,-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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 may be subject to 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.
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Page 2 - Mr. John Gillespie
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 (OS) 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/ReportalProblem/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,
for
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
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4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K121343
Device Name: Modulap Loop
Indications for Use:
The Modulap Loop is intended for monopolar electrosurgical coagulation/cutting during laparoscopic surgery. It is indicated for the amputation of the uterus during supracervical hysterectomy and for resection of pedunculated subserosal (abdominal) myomas.
It is not intended for use in hysteroscopy or for contraceptive coagulation of the fallopian tubes.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Herbert P. Lerner -S
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).