(134 days)
No
The summary describes a mechanical device (balloon catheter) for dilation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "therapeutic procedures."
No
The device is described as an instrument intended to dilate sinus ostia and spaces for diagnostic AND therapeutic procedures, meaning its primary function is not solely diagnostic.
No
The device description explicitly states it is a "catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description and Intended Use: The description and intended use clearly state that the Relieva Sinus Balloon Catheter and Relieva Acella Sinus Balloon Catheter are instruments used to physically dilate sinus ostia and spaces within the paranasal sinus cavities. This is a therapeutic and diagnostic procedure performed directly on the patient's body, not on a specimen taken from the body.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any biological specimens.
Therefore, the device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
Product codes
LRC, KAM
Device Description
The Relieva Sinus Balloon Catheter is a catheter designed to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.
The Relieva Acella Sinus Balloon Catheter is a catheter designed to access and to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus ostia and spaces within the paranasal sinus cavities; maxillary sinus
Indicated Patient Age Range
adults and 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)
The Relieva Sinus Balloon Catheter met all performance acceptance criteria.
The Relieva Acella Sinus Balloon Catheter met all performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Relieva Sinus Balloon Catheter (K043527), Relieva Acella Sinus Balloon Catheter (K061903)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 the limitations in § 878.9.
0
Acclarent
Traditional 510(k)
2008
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 | MAR 1 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Contact Person: | Keri Yen
Regulatory Affairs Specialist
Phone: (650) 687-5874
Fax: (650) 687-4449 | |
| Date of Submission: | October 26, 2007 | |
| Device Trade Name: | Relieva™ Sinus Balloon Catheter
Relieva Acella™ Sinus Balloon Catheter | |
| Common Name: | Sinus Balloon Catheter
Sinus Balloon Catheter—Integrated Wire | |
| Device Classification: | Class I | |
| Regulation Number: | 21 CFR 874.4420 | |
| Classification Name: | ENT Manual Surgical Instrument | |
| Product Code: | LRC | |
| Predicate Devices: | Relieva Sinus Balloon Catheter (K043527)
Relieva Acella Sinus Balloon Catheter (K061903) | |
| Device Description: | The Relieva Sinus Balloon Catheter is a catheter designed to
dilate the sinus ostia and paranasal spaces in adults and
maxillary sinus spaces in children.
The Relieva Acella Sinus Balloon Catheter is a catheter
designed to access and to dilate the sinus ostia and paranasal
spaces in adults and maxillary sinus spaces in children. | |
| Indications for Use: | Relieva Sinus Balloon Catheter is an instrument intended to
dilate sinus ostia and spaces within the paranasal sinus cavities
for diagnostic and therapeutic procedures. For children aged
17 and under, the balloon catheter system is intended to dilate
sinus ostia and spaces associated with the maxillary sinus for
diagnostic and therapeutic procedures.
Relieva Acella Sinus Balloon Catheter is an instrument
intended to dilate sinus ostia and spaces within the paranasal
sinus cavities for diagnostic and therapeutic procedures. For
children aged 17 and under, the balloon catheter system is
intended to dilate sinus ostia and spaces associated with the
maxillary sinus for diagnostic and therapeutic procedures. | |
| Technological
Characteristics: | The Relieva Sinus Balloon Catheter and the Relieva Acella
Sinus Balloon Catheter utilize a balloon to dilate blocked nasal
passageways. The balloon is inflated with a high pressure
inflation device. | |
| Performance Data: | The Relieva Sinus Balloon Catheter met all performance
acceptance criteria. | |
| | The Relieva Acella Sinus Balloon Catheter met all
performance criteria. | |
| Summary of Substantial
Equivalence: | The clarifying statement added to the indications for use does
not impact the intended use, performance, fundamental
scientific technology, or safety and effectiveness of the subject
device and therefore the subject device is substantially
equivalent to the predicate devices. | |
| | The Relieva Sinus Balloon Catheter and the Relieva Acella
Sinus Balloon Catheter are substantially equivalent to the
predicate devices. | |
APPENDIX A: 510(k) SUMMARY
1
Image /page/1/Picture/1 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line appears above the right side of the word, starting above the 'e' and extending to the right. The text is black against a white background.
Relieva™ Sinus Balloon Catheter
Relieva Acella™ Sinus Balloon Catheter
Traditional 510(k)
2
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2008
Acclarent, Inc c/o Keri Yen 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K073041
Trade/Device Name: Relieva™ Sinus Balloon Catheter Relieve™ Acella Sinus Balloon Catheter Regulation Number: 21 CFR 874.4800 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: KAM Dated: February 18, 2008 Received: February 19, 2008
Dear Ms. Yen:
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, Trug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 af 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Maling B. Epple, M.D.
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the word "Acclarent" in a bold, sans-serif font. There is a curved line above the word, starting from the "A" and ending near the "t". The text is black against a white background.
Traditional 510(k)
Relieva™ Sinus Balloon Catheter Relieva Acella™ Sinus Balloon Catheter
APPENDIX B: INDICATIONS FOR USE STATEMENT
K073041 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): Relieva™ Sinus Balloon Catheter Trade Name: Relieva™ Acella Sinus Balloon Catheter Sinus Balloon Catheter Common Name: Sinus Balloon Catheter-Integrated Wire Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus Indications For Use: ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. Prescription Use Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(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)
Khen & Baken
(Division Sian-Off Division of Ophthalmic Ea Nose and Throat Devise
510(k) Number K073041