(73 days)
No
The device description and performance studies indicate a manual surgical instrument with no mention of AI or ML capabilities.
Yes
The device is intended for the "treatment of simple anal fistulae" by "manipulating soft tissue (cutting)", which directly addresses a disease condition.
No
Explanation: The device is described as a "manual cutting instrument" intended for "manipulating soft tissue (cutting) for treatment of simple anal fistulae" and "circumferential tissue removal". Its components are designed for mechanical action (probe, guide, base plate, circular cutter). There is no mention of it collecting, analyzing, or interpreting biological signals, images, or data to diagnose a condition.
No
The device description clearly outlines multiple physical components made of stainless steel and PVC, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae." This describes a surgical instrument used directly on the patient's body for treatment.
- Device Description: The description details a manual cutting instrument with components like a probe, guide, base plate, and circular cutter. These are all physical tools used for surgical manipulation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information for diagnosis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The device is clearly a surgical instrument for therapeutic intervention, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.
Product codes
KOA
Device Description
FiXcision is an EO-sterilized, single use, multi-part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae. The four components include the following:
- Probe: Component made of stainless steel that passes through the fistula tract.
- Guide: Component made of stainless steel that compresses tissue within the fistula tract.
- Base Plate: Component made of stainless steel that acts as a stop for the Circular ● Cutter.
- Circular Cutter: Component made of stainless steel and polyvinyl chloride (PVC-U). The Circular Cutter cuts tissue from fistula tract. The distal end of the Circular Cutter has a protective cap made of silicone that is removed prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No FDA performance standards have been established for FiXcision. The following nonclinical testing has been performed in order to demonstrate equivalence to the predicate device:
- Sterilization and shelf life validation
- Biocompatibility testing:
- Cytotoxicity per ISO 10993-5
- Sensitization per 10993-10
- Irritation per 10993-10
- Performance testing (bench):
- Design validation
- Wear of the cutting edge of the Circular Cutter
- Tensile force of the Circular Cutter
- Bending test for the Probe
- Strength of screwed end of the Guide
- Usability per IEC 62366-1
- Design validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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December 7, 2018
Agency for Medical Innovations GmbH % Allison C. Komiyama, Ph.D., R.A.C. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave., Suite B-257 San Diego, CA 92110
Re: K182664
Trade/Device Name: FiXcision Regulation Number: 21 CFR§ 876.4730 Regulation Name: Manual Gastroenterology-Urology Surgical Instrument and Accessories Regulatory Class: I Product Code: KOA Dated: September 21, 2018 Received: September 25, 2018
Dear Allison C. Komiyama:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeffrey W. Cooper -S
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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Indications for Use
510(k) Number (if known) K182664
Device Name FiXcision
Indications for Use (Describe)
The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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K182664 Page 1 of 3
510(k) Summary K182664
DATE PREPARED
December 5, 2018
MANUFACTURER AND 510(k) OWNER
Agency for Medical Innovations GmbH Im Letten 1, 6800 Feldkirch, Vorarlberg, Austria Telephone: +43 5522 90505-0 Fax: +43 5522 90505-4006 Official Contact: Martin Hohlrieder, Ph.D., CTO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Michelle Rubin-Onur, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
FiXcision
COMMON NAME
Surgical Instruments, Gastroenterology-Urology, Manual (And Accessories)
DEVICE CLASSIFICATION
Manual gastroenterology-urology surgical instrument and accessories (21 CFR 876.4730, Product Code KOA, Class I)
PREMARKET REVIEW
ODE/DRGUD/GEDB Gastroenterology Devices Branch
INDICATIONS FOR USE
The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.
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Image /page/4/Picture/1 description: The image shows the logo for A.M.I. The letters are in blue and are large and bold. There are three gray circles below the letters, one below each letter. There is a registered trademark symbol to the right of the last letter.
DEVICE DESCRIPTION
FiXcision is an EO-sterilized, single use, multi-part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae. The four components include the following:
- Probe: Component made of stainless steel that passes through the fistula tract.
- Guide: Component made of stainless steel that compresses tissue within the fistula tract.
- Base Plate: Component made of stainless steel that acts as a stop for the Circular ● Cutter.
- Circular Cutter: Component made of stainless steel and polyvinyl chloride (PVC-U). The Circular Cutter cuts tissue from fistula tract. The distal end of the Circular Cutter has a protective cap made of silicone that is removed prior to use.
PREDICATE DEVICE IDENTIFICATION
The FiXcision device is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K760715 | Flexible Cutting Scissors / V. Mueller O.V. | |
| Baxter Healthcare Corp. | ✓ |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for FiXcision. The following nonclinical testing has been performed in order to demonstrate equivalence to the predicate device:
- Sterilization and shelf life validation
- . Biocompatibility testing:
- Cytotoxicity per ISO 10993-5 .
- . Sensitization per 10993-10
- Irritation per 10993-10
- . Performance testing (bench):
- . Design validation
- Wear of the cutting edge of the Circular Cutter .
- . Tensile force of the Circular Cutter
- . Bending test for the Probe
- 트 Strength of screwed end of the Guide
- Usability per IEC 62366-1
- . Design validation
EQUIVALENCE TO PREDICATE DEVICE
The subject device has equivalent intended use and similar technological characteristics as the device cleared in K760715. Unlike the predicate device that had a general intended use for cutting, FiXcision has specific indications to only be used on patients who have simple anal fistulae. Unlike the straight blade(s) of the predicate, FiXcision
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cuts tissue using a tubular blade. This technological characteristic has undergone testing to ensure the device is substantially equivalent to the predicate.
CONCLUSION
Based on the testing performed, including biocompatibility, sterilization and shelf life validation, and non-clinical performance testing (bench), it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar intended use, technological characteristics, and performance characteristics for the proposed FiXcision device are assessed to be substantially equivalent to the predicate device.