(85 days)
The Relieva Luma™ Sinus Illumination System is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.
The Relieva Luma™ Sinus Illumination System is a flexible device that transmits light at the distal tip. The system also contains two accessories: a light cable and an adapter.
The provided text describes the Relieva Luma™ Sinus Illumination System and its 510(k) submission. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a definitive study proving the device meets them.
The document states: "The Relieva Luma™ Sinus Illumination System met all performance testing acceptance criteria." and "The Relieva Luma™ Sinus Illumination System is substantially equivalent to the predicate device as confirmed through relevant performance tests."
This indicates that some performance testing was conducted, and the device met its criteria, but the specifics of what those criteria were, how the tests were performed, and the results (beyond a statement of "met all criteria") are not included in the provided text.
Based on the available information, here is what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Met all performance testing acceptance criteria. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document. This device is a manual surgical instrument, so "ground truth" would likely relate to its mechanical function, optical properties, or safety profile, rather than diagnostic accuracy established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't explicitly detailed for this device's performance testing.
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
An MRMC study is not mentioned in the document. This type of study focuses on diagnostic systems, often involving AI, which is not the primary function described for the Relieva Luma™ Sinus Illumination System. The device is a "manual surgical instrument for general use" that provides illumination and access.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance evaluation (algorithm only) is not applicable as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For a physical device like this, "ground truth" would likely relate to objective measurements of its physical and optical characteristics (e.g., light output, flexibility, durability, biocompatibility), rather than diagnostic "ground truth" derived from expert consensus or pathology.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as in point 8.
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SEP 2 8 7007
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APPENDIX A: 510(k) SUMMARY
| APPENDIX A: 510(k) SUMMARY | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
| Contact Person: | Keri YenRegulatory Affairs SpecialistPhone: (650) 687-5874Fax: (650) 687-4449 |
| Date of Submission: | July 3, 2007 |
| Device Trade Name: | Relieva Luma™ Sinus Illumination System |
| Common Name: | Sinus Guidewire |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 878.4800 |
| Classification Name: | Manual surgical instrument for general use |
| Product Code: | KAM |
| Predicate Device: | Relieva™ Sinus Guidewire (K043445) |
| Device Description: | The Relieva Luma™ Sinus Illumination System is a flexible devicethat transmits light at the distal tip. The system also contains twoaccessories: a light cable and an adapter. |
| Indications for Use: | The Relieva Luma™ Sinus Illumination System is intended to providemeans to access the sinus space for diagnostic and therapeuticprocedures in conjunction with other nasal and sinus products. It isalso intended to illuminate within and transilluminate across nasal andsinus structures. |
| TechnologicalCharacteristics | The Relieva Luma™ Sinus Illumination System is a device thatallows for access to the desired sinus space. Light from the distal tipof the device can be seen via transillumination. The device isconnected to any standard light source via a light cable and anadapter. |
| Performance Data | The Relieva Luma™ Sinus Illumination System met all performancetesting acceptance criteria. |
| Summary ofSubstantialEquivalence: | The Relieva Luma™ Sinus Illumination System is substantiallyequivalent to the predicate device as confirmed through relevantperformance tests. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2007
Acclarent, Inc. c/o Keri Yen Regulatory Affairs Specialist 1525-B O'Brien Drive Menlo Park, CA 90425
Re: K071845
Trade/Device Name: Relieva Luma™ Sinus Illumination System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: KAM Dated: August 30, 2007 Received: August 31, 2007
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, 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.
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 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); 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 yours.
M.B. Eylerus, MD
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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KO7184S
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K071845
Relieva Luma™ Sinus Illumination System Trade Name: Sinus Guidewire Common Name: The Relieva Luma™ Sinus Illumination System is intended to provide a Indications For Use: means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
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(Posted November 13, 2003)
Division Sign-Division of Ophthalmic Ea Nose and Throat D
510(k) Number
§ 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.