(115 days)
Intended Use: The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
Indications for Use: The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.
The Sinus Dilation System with Cannulated Instrument consists of a disposable balloon which is mounted on a reusable cannulated delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic guidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to guide the device to the sinus ostium using endoscopic visualization. The instrument cannulation provides a working channel for suction, irrigation, etc.
The provided document K131709 describes a "Sinus Dilation System with Cannulated Instrument." The submission is a Special 510(k) notice for a modification to a previously cleared device (ENTrigue® Sinus Dilation System, K121351).
This type of device is classified as a Class I medical device (exempt from 510(k) requirements) under 21 C.F.R. § 874.4420, an "Ear, Nose, and Throat manual Surgical Instrument" with product code LRC. Due to its classification and the nature of the submission (Special 510(k) for a modification), the regulatory requirements for showing effectiveness through clinical studies involving human patients, as would be expected for AI/diagnosis devices, are not applicable here.
The "acceptance criteria" and "device performance" in this context refer to engineering and biocompatibility testing rather than diagnostic performance metrics like sensitivity, specificity, or AUC which are typical for AI/CADe devices.
Here's an analysis based on the provided text, indicating what information is present and absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Description of Test/Criteria | Reported Device Performance/Conclusion |
|---|---|
| Device Modification: | The Sinus Dilation System with Cannulated Instrument is a modification to ENTrigue® Sinus Dilation System. The modification includes a minor difference in handle design and cannulation of the reusable delivery instrument. |
| User Requirements: | The instrument design met user requirements. |
| Fatigue Life: | Instrument testing included fatigue life. The device functioned as intended and results were as expected. |
| Human Factors Verification: | Instrument testing included human factors verification. The device functioned as intended and results were as expected. |
| Ability to Articulate and Lock: | Instrument testing included ability to articulate and lock. The device functioned as intended and results were as expected. |
| Cleaning and Sterilization: | Instrument testing included cleaning and sterilization validations. The device functioned as intended and results were as expected. |
| Substantial Equivalence: | Bench testing confirmed the Sinus Dilation System with Cannulated Instrument is substantially equivalent to the legally marketed predicate device, the ENTrigue® Sinus Dilation System (K121351). Verification and validation testing confirms that the modifications do not raise any new risks and the device has the same intended use, similar indications, principles of operation, and technological characteristics. The minor differences do not alter the fundamental scientific technology. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes (e.g., number of units tested) for the bench tests (fatigue life, human factors, articulation/lock, cleaning/sterilization). It only states that "Bench testing was conducted."
- Data Provenance: The data is from "Bench testing," meaning it was conducted in a laboratory or manufacturing environment. There is no mention of country of origin for the data or whether it was retrospective or prospective, as this is laboratory testing, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This question is not applicable to this type of device and study. The "ground truth" for a mechanical device's performance (like articulating, locking, or fatigue life) is generally based on engineering specifications and validated testing protocols, not expert clinical interpretation of data. Human factors verification might involve users (physicians or other healthcare personnel), but their number or qualifications as "experts to establish ground truth" in the diagnostic sense is not relevant here and not specified.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers when establishing ground truth for diagnostic decisions. Since this is a submission for a mechanical device based on bench testing, such methods are not relevant or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant to diagnostic devices, particularly AI-driven ones where human readers' performance is compared with and without AI assistance. This submission is for a mechanical surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study was not done. This concept is only applicable to AI/algorithm-based diagnostic devices. The device in question is a physical surgical instrument; its performance is always "human-in-the-loop" as it is operated by a surgeon.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on engineering specifications and validated test protocols. For example, a successful fatigue life test means the device withstood a specified number of cycles without failure, as per its design requirements. Successful cleaning and sterilization validation means it met established standards for those processes. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of a physical surgical instrument modification. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
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510(k) SUMMARY
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Sinus Dilation System with Cannulated Instrument
| Sponsor: | ArthroCare Corporation12672 Silicon Drive, Suite 150San Antonio, Texas 78249 USATelephone: 1-877-300-5010Fax: 1-210-298-6399Contact Person: Gabriele G. Niederauer, Ph.D. |
|---|---|
| OCT 0 4 2013 | |
| Date Prepared: | September 17, 2013 |
| Trade Name: | Sinus Dilation System with Cannulated Instrument |
| Product Code andDevice Classification Name: | LRCSinus Dilation System (21 C.F.R. § 874.4420) |
| Classification:Predicate Device(s): | Class I (exempt from 510(k) requirements)ENTrigue Surgical, Inc. ENTrigue® Sinus Dilation System[K121351] |
| Purpose of theSpecial 510(k) notice: | The Sinus Dilation System with Cannulated Instrument is amodification to ENTrigue® Sinus Dilation System. |
| Intended Use: | The Sinus Dilation System with Cannulated Instrument isintended for use in surgical procedures to access, examine ortreat the nasal and paranasal tissues leading to ostia. |
| Indications for Use: | The Sinus Dilation System with Cannulated Instrument isindicated to access and treat the frontal recesses, sphenoidsinus ostia, and maxillary ostia/ethmoid infundibula in adultsusing a trans-nasal approach. |
| Technological:Characteristics | The Sinus Dilation System with Cannulated Instrumentconsists of a disposable balloon which is mounted on areusable cannulated delivery instrument to allow for dilation ofsinus ostia in the paranasal cavity under endoscopic guidance.The Sinus Balloon components include a balloon sleeve toslide over the tip of the delivery instrument, a connecting collarto latch the balloon sleeve to the delivery instrument, and aninflation line to connect to the balloon inflation device. Thefeatures of this device enable a physician to guide the device |
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to the sinus ostium using endoscopic visualization. The instrument cannulation provides a working channel for suction, irrigation, etc.
The Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The cannulated delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures.
Performance Data: Bench testing was conducted to validate that the instrument design met user requirements and test results confirmed that the Sinus Dilation System with Cannulated Instrument is substantially equivalent to the legally marketed predicate device the ENTrique® Sinus Dilation System. Instrument testing included fatigue life, human factors verification, ability to articulate and lock, cleaning and sterilization validations. In all instances, the Sinus Dilation System with Cannulated Instrument functioned as intended and the results observed were as expected.
The Sinus Dilation System with Cannulated Instrument has the same intended use and similar indications, principles of operation, and technological characteristics as ENTrigue® Sinus Dilation System. The minor difference in handle design and cannulation of the reusable delivery instrument does not alter the fundamental scientific technology. Verification and validation testing confirms that the modifications do not raise any new risks. Thus, the Sinus Dilation System with Cannulated Instrument is substantially equivalent to its predicate devices.
Substantial Equivalence:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
October 4, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MI) 20993-002
ArthroCare, Inc. % Gabrielle G. Niederauer, Ph.D. Senior Director, R & D 7000 W. William Cannon Dr., Bldg. 1 Austin. TX 78735
Re: K131709
Trade/Device Name: Sinus dilation system with cannulated instrument Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: September 5, 2013 Received: September 6, 2013
Dear Dr. Niederauer:
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 enacunent 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. Iisting 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.
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Page 2 - Gabrielle G. Niederauer, Ph.D.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eric Ayman -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K131709
Device Name: Sinus Dilation System with Cannulated Instrument
Intended Use:
The Sinus Dilation System with Cannulated Instrument is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
Indications for Use:
The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostialethmoid infundibula in adults using a transnasal approach.
Prescription Use _ × (Per 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Par 2013.10.03 14:00
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(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 § 874.9.