(134 days)
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.
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.
The provided FDA 510(k) summary for the Acclarent Relieva™ Sinus Balloon Catheter and Relieva Acella™ Sinus Balloon Catheter indicates that the devices met all performance acceptance criteria. However, due to the nature of this submission (a traditional 510(k) for a medical device that does not involve AI/software for diagnostic purposes), the detailed information typically associated with AI/software performance studies is not present.
Here's an analysis of what can and cannot be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All performance acceptance criteria (specific criteria not detailed in this summary) | Met all performance acceptance criteria. |
Reasoning: The document states, "The Relieva Sinus Balloon Catheter met all performance acceptance criteria. The Relieva Acella Sinus Balloon Catheter met all performance criteria." However, it does not elaborate on what those specific criteria were. This is typical for a 510(k) summary for a physical medical device. The criteria would likely involve physical performance metrics like burst pressure, inflation/deflation times, material biocompatibility, and sterilization effectiveness, rather than diagnostic accuracy metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document focuses on the physical device and its equivalence to predicates, not on clinical data in the way an AI diagnostic device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not specified. This device is a physical surgical instrument for dilation, not an AI device that requires expert ground truth for interpretation of medical images or data. Performance testing would likely involve engineering and clinical performance in a procedural context, not expert interpretation of outputs.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified. This concept is relevant for AI image analysis where disagreements between readers need to be resolved to establish ground truth. For a physical device, performance is evaluated against engineering specifications and clinical outcomes in usability/safety studies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for this physical balloon catheter device.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For a physical medical device like this, "ground truth" would relate to engineering specifications, material properties, and clinical outcomes (e.g., successful dilation, lack of tissue trauma, safety data) from usability/performance studies. The document does not specify the exact nature of the performance data (e.g., in-vitro bench testing, animal studies, or specific human clinical data beyond general statements of equivalence) or how "ground truth" for those outcomes was established, although it would inherently be based on direct measurement and observation rather than expert interpretation of a model's output.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
In summary: The provided document is a 510(k) summary for a physical medical device (balloon catheter) under Class I (Low Risk). It confirms that the device met all specified performance criteria, but the detail expected for an AI performance study (e.g., sample sizes for test/training, expert qualifications, adjudication, MRMC studies) is not present because those concepts are not relevant to this type of device submission. The submission is focused on demonstrating substantial equivalence to predicate physical devices.
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Acclarent
Traditional 510(k)
2008
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 | MAR 1 |
|---|---|---|
| Contact Person: | Keri YenRegulatory Affairs SpecialistPhone: (650) 687-5874Fax: (650) 687-4449 | |
| Date of Submission: | October 26, 2007 | |
| Device Trade Name: | Relieva™ Sinus Balloon CatheterRelieva Acella™ Sinus Balloon Catheter | |
| Common Name: | Sinus Balloon CatheterSinus 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 todilate the sinus ostia and paranasal spaces in adults andmaxillary sinus spaces in children.The Relieva Acella Sinus Balloon Catheter is a catheterdesigned to access and to dilate the sinus ostia and paranasalspaces in adults and maxillary sinus spaces in children. | |
| Indications for Use: | Relieva Sinus Balloon Catheter is an instrument intended todilate sinus ostia and spaces within the paranasal sinus cavitiesfor diagnostic and therapeutic procedures. For children aged17 and under, the balloon catheter system is intended to dilatesinus ostia and spaces associated with the maxillary sinus fordiagnostic and therapeutic procedures.Relieva Acella Sinus Balloon Catheter is an instrumentintended to dilate sinus ostia and spaces within the paranasalsinus cavities for diagnostic and therapeutic procedures. Forchildren aged 17 and under, the balloon catheter system isintended to dilate sinus ostia and spaces associated with themaxillary sinus for diagnostic and therapeutic procedures. | |
| TechnologicalCharacteristics: | The Relieva Sinus Balloon Catheter and the Relieva AcellaSinus Balloon Catheter utilize a balloon to dilate blocked nasalpassageways. The balloon is inflated with a high pressureinflation device. | |
| Performance Data: | The Relieva Sinus Balloon Catheter met all performanceacceptance criteria. | |
| The Relieva Acella Sinus Balloon Catheter met allperformance criteria. | ||
| Summary of SubstantialEquivalence: | The clarifying statement added to the indications for use doesnot impact the intended use, performance, fundamentalscientific technology, or safety and effectiveness of the subjectdevice and therefore the subject device is substantiallyequivalent to the predicate devices. | |
| The Relieva Sinus Balloon Catheter and the Relieva AcellaSinus Balloon Catheter are substantially equivalent to thepredicate devices. |
APPENDIX A: 510(k) SUMMARY
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Relieva™ Sinus Balloon Catheter
Relieva Acella™ Sinus Balloon Catheter
Traditional 510(k)
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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.
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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
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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
§ 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.