(29 days)
Not Found
No
The summary describes a mechanical device for sinus dilation and illumination, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The intended use section states that the device is for "diagnostic and therapeutic procedures," and the device description explains how the balloon is used to "dilate" sinus spaces, which is a therapeutic action.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for "diagnostic and therapeutic procedures."
No
The device description explicitly lists physical components like a rail, balloon catheter, illumination system, and handle, indicating it is a hardware-based medical device.
Based on the provided information, the Relieva Scout Sinus Dilation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for diagnostic and therapeutic procedures related to the frontal sinus. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical device with a balloon catheter and illumination system designed for direct interaction with anatomical structures. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Relieva Scout Sinus Dilation System is an in vivo medical device used for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LRC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal sinus space, frontal recess, frontal sinus ostia, frontal sinus cavity, nasal and sinus structures
Indicated Patient Age Range
18 and older
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation will be the overkill (half-cycle approach) in a fixed chamber. Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic".
Packaging shelf life was established at one year via accelerated aging per ASTM F1980-07.
The performance data demonstrate that the device performs as intended.
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.
Relieva Seeker Balloon Sinuplasty System (K120280)
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
§ 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.
0
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 Drive
Menlo Park, California 94025 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II
Senior Manager, Regulatory Affairs
Phone: 650 687-4807
Fax: (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 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. |
| 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. |
1
Modified Sinus Dilation System
| Technological
Characteristics: | The Scout Balloon Sinuplasty System combines features of a frontal
ostium seeker with the tissue expansion effect of balloon dilation. The
distal end of the device is permanently curved to optimize frontal
ostium access. Light from an extendable integrated illumination system
can be seen via transillumination. Additionally, the Scout Balloon
Sinuplasty System allows for the manual wire adjustment to provide
balloon navigational assistance. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | 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 and demonstrated a sterility assurance level of 10-6. The method
used for sterilization validation will be the overkill (half-cycle
approach) in a fixed chamber. Testing of ethylene oxide residuals met
ISO 10993-7:2008 requirements. The subject device is not tested nor
labeled as "non-pyrogenic".
Packaging shelf life was established at one year via accelerated aging
per ASTM F1980-07.
The performance data demonstrate that the device performs as intended. |
| Summary of Substantial
Equivalence: | The Relieva Scout Sinus Dilation System is substantially equivalent to
the predicate device. |
2
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.
3
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
4
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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