(280 days)
No
The summary describes a mechanical device for dilation and illumination, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The intended use explicitly states the device is for "diagnostic and therapeutic procedures," and its function involves dilating frontal sinus spaces, which is a therapeutic action.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "diagnostic and therapeutic procedures."
No
The device description explicitly states it is an "integrated device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and a handle," which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for diagnostic and therapeutic procedures within the frontal sinus. This involves physically accessing, dilating, and illuminating structures within the body.
- Device Description: The device description details a system with a rail, balloon catheter, illumination system, and handle, all designed for physical intervention within the sinus cavity.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of biological specimens outside the body.
The device is clearly intended for direct use within the patient's body for both diagnostic (illumination) and therapeutic (dilation) purposes. This aligns with the definition of a medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty 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 Seeker Balloon Sinuplasty System (Seeker) is an integrated device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and a 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 Seeker Balloon Sinuplasty System is biocompatible. Sterilization of the subject device is achieved by ethylene oxide, which was validated according to AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10 °. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic". Packaging shelf life was established per ASTM F1980-07, ISTA 2A:2011, ASTM F88-09, ASTM F2096-11, F1886, and F1929-98 requirements. Clinical data were not necessary for the Seeker Balloon Sinuplasty System. 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.
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.
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
120080
NOV 5 2012
510(k) SUMMARY
Sponsor/Submitter: Acclarent, Inc. 1525-B O'Brien Drive Menlo Park, California 94025 Contact Person: Daniel Harfe Director, Clinical and Regulatory Affairs Phone: (650) 687-6056 Fax: (650) 687-4847 January 27, 2012 Date of Submission: Device Trade Name: Relieva Seeker Balloon Sinuplasty System Common Name: Sinus Dilation System Device Classification: Class I 21 CFR 874.4420 Regulation Number: Ear, Nose, and Throat Manual Surgical Instrument Classification Name: LRC Product Code: Predicate Devices: Relieva Spin Sinus Dilation System (K111875) Entellus Medical XprESS Multi-Sinus Dilation Tool (K102003) Relieva Luma Sinus Illumination System (K071845) The Relieva Seeker Balloon Sinuplasty System (Seeker) is an integrated Device Description: device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and a handle. The sinus balloon may be inflated to dilate the frontal recess, frontal sinus ostia, and
spaces within the frontal sinus cavity.
1
Indications for Use:
For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty 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.
Technological Characteristics: The Seeker 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.
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 Seeker Balloon Sinuplasty System is biocompatible.
Sterilization of the subject device is achieved by ethylene oxide, which was validated according to AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10 °. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic".
Packaging shelf life was established per ASTM F1980-07, ISTA 2A:2011, ASTM F88-09, ASTM F2096-11, F1886, and F1929-98 requirements.
Clinical data were not necessary for the Seeker Balloon Sinuplasty System. The performance data demonstrate that the device performs as intended.
The Relieva Seeker Sinus Dilation System is substantially equivalent to the predicate devices
Summary of Substantial Equivalence:
2
NOV
5 200
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Acclarent, Inc. % Mr. Daniel Harfe Director, Regulatory & Clinical, Rhinology 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K120280
Trade/Device Name: Relieva Seeker Balloon Sinuplasty System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: October 19, 2012 Received: October 22, 2012
Dear Mr. Harfe:
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, 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. 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
3
Page 2 - Mr. Daniel Harfe
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K120280 |
|---|---|
| Trade Name: | Relieva Seeker Balloon Sinuplasty™ System |
| Common Name: | Sinus Dilation System |
| Indications For Use: | For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty 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)
(Posted November 13, 2003)
Daniel C. Clapp
Page / of
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K120280 510(k) Number_