(29 days)
For patients aged 18 and older, the Relieva Scout ™ Sinus Dilation System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
The Relieva Scout Sinus Dilation System is an integrated device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and an ergonomic handle. The sinus balloon may be inflated to dilate the frontal recess, frontal sinus ostia, and spaces within the frontal sinus cavity.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/algorithm based technology. The document describes a "Relieva Scout™ Sinus Dilation System", which is a manual surgical instrument, not an AI or algorithm-based device.
The "Performance Data" section (on page 1) mentions:
- Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, balloon burst, and bond separation.
- Testing also showed that the Scout Balloon Sinuplasty System is biocompatible.
- The sterilization process was validated per AAMI/ANSI/ISO 11135-1:2007.
- Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements.
- Packaging shelf life was established via accelerated aging per ASTM F1980-07.
This information refers to engineering and material-based performance, not the kind of AI-driven performance (like sensitivity, specificity, or reader improvement) that would require the specific details you've asked for (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance).
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Image /page/0/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo consists of the word "Acclarent" in a bold, sans-serif font, with a curved line above the letters "ent". Below the logo is the text "Modified Sinus Dilation System" in a smaller, sans-serif font. The text indicates that Acclarent specializes in products related to sinus dilation.
FEB 2 0 2014 Special 510(k)
APPENDIX A: 510(K) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
|---|---|
| Contact Person: | James Patrick Garvey IISenior Manager, Regulatory AffairsPhone: 650 687-4807Fax: (650) 687-4449 |
| Date of Submission: | January 17, 2014 |
| Device Trade Name: | Relieva Scout ™ Sinus Dilation System |
| Common Name: | Sinus Dilation System |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, Nose, and Throat Manual Surgical Instrument |
| Product Code: | LRC |
| Predicate Device: | Relieva Seeker Balloon Sinuplasty System (K120280) |
| Device Description: | The Relieva Scout Sinus Dilation System is an integrated device with alow-profile rail, balloon catheter, sinus illumination system with anilluminated ball tip, and an ergonomic handle. The sinus balloon maybe inflated to dilate the frontal recess, frontal sinus ostia, and spaceswithin the frontal sinus cavity. |
| Indications for Use: | For patients aged 18 and older, the Relieva Scout ™ Sinus DilationSystem is intended to provide a means to access the frontal sinus spaceand to dilate the frontal recess, frontal sinus ostia and spaces within thefrontal sinus cavity for diagnostic and therapeutic procedures. Inaddition, the device is intended to illuminate within and transilluminateacross nasal and sinus structures. |
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Modified Sinus Dilation System
| TechnologicalCharacteristics: | The Scout Balloon Sinuplasty System combines features of a frontalostium seeker with the tissue expansion effect of balloon dilation. Thedistal end of the device is permanently curved to optimize frontalostium access. Light from an extendable integrated illumination systemcan be seen via transillumination. Additionally, the Scout BalloonSinuplasty System allows for the manual wire adjustment to provideballoon navigational assistance. |
|---|---|
| Performance Data: | Bench testing met all acceptance criteria for attributes such asdimensional attributes, cycle fatigue, balloon burst, and bondseparation. Testing also showed that the Scout Balloon SinuplastySystem is biocompatible.The sterilization process was validated per AAMI/ANSI/ISO 11135-1:2007 and demonstrated a sterility assurance level of 10-6. The methodused for sterilization validation will be the overkill (half-cycleapproach) in a fixed chamber. Testing of ethylene oxide residuals metISO 10993-7:2008 requirements. The subject device is not tested norlabeled as "non-pyrogenic".Packaging shelf life was established at one year via accelerated agingper ASTM F1980-07.The performance data demonstrate that the device performs as intended. |
| Summary of SubstantialEquivalence: | The Relieva Scout Sinus Dilation System is substantially equivalent tothe predicate device. |
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2014
Acclarent . Inc. % Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs, Acclarent Inc. 1525-B O'Brien Drive Menlo Park, California 94025
Re: K140160
Trade/Device Name: Relieva Scout Sinus Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: January 22, 2014 Received: January 22, 2014
Dear Mr. Garvey:
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. 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 - Mr. James Patrick Garvey II
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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.
Eric A. Mann -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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Special 510(k)
APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K140160 |
|---|---|
| Trade Name: | Relieva Scout™ Balloon Dilation System |
| Common Name: | Sinus Dilation System |
| Indications For Use: | For patients aged 18 and older, the Relieva Scout Sinus Dilation System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures. |
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
| AND/OR | |
| Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sageev George -S 2014.02.20 15:23:02 -05'00'
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§ 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.