(128 days)
Not Found
No
The summary describes a mechanical device for sinus procedures and makes no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic procedures" in multiple contexts (dilating sinus ostia and spaces, and irrigating from within a target sinus).
Yes
The intended use statement explicitly mentions that the device is used for "diagnostic procedures" or "to facilitate diagnostic procedures" across both adult and pediatric indications.
No
The device description explicitly lists physical components like a Handle, Guidewire, Sinus Balloon Catheter, and Guide Catheter, indicating it is a hardware-based system.
Based on the provided information, the Relieva SpinPlus Balloon Sinuplasty System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures within the nasal and sinus cavities. It involves accessing, illuminating, dilating, and irrigating these anatomical structures. This is a therapeutic and diagnostic procedure performed directly on the patient's body.
- Device Description: The device components (Handle, Guidewire, Balloon Catheter, Guide Catheter) are consistent with surgical instruments used for accessing and manipulating anatomical structures.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Relieva SpinPlus does not perform any analysis of biological specimens.
- Anatomical Site: The device is used directly within the patient's sinus space and nasal structures.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the device itself (simulated use, dimensions, fatigue, burst, flow rate, light output, biocompatibility, sterilization, shelf life), not on the accuracy or reliability of diagnostic information derived from analyzing specimens.
In summary, the Relieva SpinPlus Balloon Sinuplasty System is a surgical device used for procedures within the patient's body, not a device used for testing biological specimens in vitro.
N/A
Intended Use / Indications for Use
The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target simus for therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.
Product codes
LRC
Device Description
The Relieva SpinPlus Balloon Sinuplasty System is an integrated device that incorporates an ergonomically designed Handle, an illuminated Guidewire, a Sinus Balloon Catheter, and a Guide Catheter. The Sinus Balloon Catheter enables sinus irrigation without instrument exchanges. The principles of operation of SpinPlus are similar to the predicate devices in allowing for access and enlargement of sinus ostia, and irrigation from within the target sinus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus, nasal, paranasal sinus cavities, maxillary sinus
Indicated Patient Age Range
all ages, For children aged 17 and under
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 simulated use testing, dimensional attributes, cycle fatigue, balloon burst, bond separation, irrigation flow rate and wire light output. Testing also showed that the SpinPlus Balloon Sinuplasty System is biocompatible.
The sterilization process has been validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals have been tested and meet ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as “non-pyrogenic”.
Packaging shelf life has been established to be 3 months per ASTM F1980-07.
Clinical data were not necessary for the SpinPlus 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)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2015
Acclarent, Inc. Pavan Sethi, Ph.D. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K143541
Trade/Device Name: Relieva SpinPlus 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: March 20, 2015 Received: March 23, 2015
Dear Dr. Sethi:
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.
1
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 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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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Indications for Use
510(k) Number (if known) K143541
Device Name Relieva SpinPlus Balloon Sinuplasty System
Indications for Use (Describe)
The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target simus for therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the "A" in black and the rest of the letters in a dark purple color. There is a curved line above the "ent" in purple.
510(K) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pavan Sethi, Ph.D.
Manager, Regulatory Affairs
Phone: (650) 687-5413
Fax: (650) 687-4847 |
| Date of Submission: | December 12, 2014 |
| Device Trade Name: | Relieva SpinPlus Balloon Sinuplasty 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 Devices: | Relieva Spin Sinus Dilation System (Primary Predicate, K111875)
Relieva Solo Elite Sinus Balloon Catheter (K111254)
Relieva Luma Sinus Illumination System (K071845) |
| Device Description: | The Relieva SpinPlus Balloon Sinuplasty System is an integrated
device that incorporates an ergonomically designed Handle, an
illuminated Guidewire, a Sinus Balloon Catheter, and a Guide Catheter.
The Sinus Balloon Catheter enables sinus irrigation without instrument
exchanges. The principles of operation of SpinPlus are similar to the
predicate devices in allowing for access and enlargement of sinus ostia,
and irrigation from within the target sinus. |
| Indications for Use: | The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide
a means to access the sinus space and illuminate within and
transilluminate across nasal and sinus structures; dilate the sinus ostia
and spaces associated with the paranasal sinus cavities for diagnostic
and therapeutic procedures; and irrigate from within a target sinus for
therapeutic procedures and to facilitate diagnostic procedures. |
| | For children aged 17 and under, the Relieva SpinPlus Balloon
Sinuplasty System is intended to: provide a means to access the sinus |
| | space and illuminate within and transilluminate across nasal and sinus
structures; dilate sinus ostia and spaces associated with the maxillary
sinus for diagnostic and therapeutic procedures; and irrigate from within
the maxillary sinus for therapeutic procedures and to facilitate
diagnostic procedures. |
| Technological
Characteristics: | The Relieva SpinPlus Balloon Sinuplasty System combines a Sinus
Guide Catheter and Handle Assembly (integrated with Sinus Balloon
Catheter, Sinus Irrigation and Illuminated Sinus Guidewire) into a
single device. |
| Performance Data: | Bench testing met all acceptance criteria for attributes such as simulated
use testing, dimensional attributes, cycle fatigue, balloon burst, bond
separation, irrigation flow rate and wire light output. Testing also
showed that the SpinPlus Balloon Sinuplasty System is biocompatible. |
| | The sterilization process has been validated per AAMI/ANSI/ISO
11135-1: 2007 and demonstrated a sterility assurance level of 10-6. The
method used for sterilization validation is the overkill (half-cycle
approach) in a fixed chamber. Ethylene oxide residuals have been
tested and meet ISO 10993-7:2008 requirements. The subject device is
not tested nor labeled as “non-pyrogenic”. |
| | Packaging shelf life has been established to be 3 months per ASTM
F1980-07. |
| | Clinical data were not necessary for the SpinPlus Balloon Sinuplasty
System. The performance data demonstrate that the device performs as
intended. |
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Image /page/4/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. There is a purple curved line above the "rent" portion of the logo.