(406 days)
Not Found
No
The device description and intended use describe a standard electrosurgical instrument with a wire loop. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on equivalence to a predicate device through standard testing, not AI/ML performance metrics.
Yes
The device is used for electrosurgical coagulation/cutting during laparoscopic surgery, which are therapeutic procedures.
No
The device is described as an electrosurgical instrument used for cutting and coagulation during laparoscopic surgery, specifically for the amputation of the uterus and resection of myomas. Its function is interventional/surgical, not diagnostic.
No
The device description clearly states it is a 5 mm laparoscopic instrument with physical components like a probe, wire loop, and sliding sheath. It is a single-use, sterile, disposable hardware device.
Based on the provided information, the Modulap Loop is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monopolar electrosurgical coagulation/cutting during laparoscopic surgery." This is a surgical procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument used for cutting and coagulation, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological material. The device interacts directly with the patient's anatomy during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Modulap Loop does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus, pedunculated subserosal (abdominal) myomas
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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) 567-0277 | |
| Fax Number: (781) 939-0726 | |
| Email: jgillespie@clovermedical.com | |
| Classification: | Coagulator-Cutter, Endoscopic, Unipolar (and |
| accessories) 21 CFR 884.4160, Product code KNF, | |
| Class II | |
| Intended Use: | The Modulap Loop is intended for the amputation of |
| the uterus during laparoscopic 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. |
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)
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Herbert P. Lerner -S