K Number
K071845
Device Name
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
Manufacturer
Date Cleared
2007-09-28

(85 days)

Product Code
Regulation Number
878.4800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
More Information

Not Found

No
The summary describes a light-transmitting device for illumination and access, with no mention of AI/ML, image processing, or data analysis capabilities.

Yes
The device is described as being intended for "diagnostic and therapeutic procedures" and is used in conjunction with other nasal and sinus products.

Yes
The "Intended Use / Indications for Use" states that the system is "intended to provide a means to access the sinus space for diagnostic and therapeutic procedures."

No

The device description explicitly states it is a "flexible device that transmits light at the distal tip" and includes "two accessories: a light cable and an adapter," indicating it is a hardware device with physical components.

Based on the provided information, the Relieva Luma™ Sinus Illumination System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes a device used in vivo (within the body) for diagnostic and therapeutic procedures within the sinus space. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
  • Device Description: The description details a flexible device that transmits light for illumination and transillumination of anatomical structures. This is consistent with an in vivo medical device, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.

Therefore, the Relieva Luma™ Sinus Illumination System is a medical device used for procedures within the body, not an IVD.

N/A

Intended Use / Indications for Use

The Relieva Luma™ Sinus Illumination System is intended to provide 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.

Product codes (comma separated list FDA assigned to the subject device)

KAM

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

sinus space, nasal and sinus structures

Indicated Patient Age Range

Not Found

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 Luma™ Sinus Illumination System met all performance testing acceptance criteria.

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.

Relieva™ Sinus Guidewire (K043445)

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.

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

§ 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.

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K071845

Acclarent / ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


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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 Drive
Menlo Park, California 94025
Contact Person:Keri Yen
Regulatory Affairs Specialist
Phone: (650) 687-5874
Fax: (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 device
that transmits light at the distal tip. The system also contains two
accessories: a light cable and an adapter.
Indications for Use:The Relieva Luma™ Sinus Illumination System is intended to provide
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.
Technological
CharacteristicsThe Relieva Luma™ Sinus Illumination System is a device that
allows for access to the desired sinus space. Light from the distal tip
of the device can be seen via transillumination. The device is
connected to any standard light source via a light cable and an
adapter.
Performance DataThe Relieva Luma™ Sinus Illumination System met all performance
testing acceptance criteria.
Summary of
Substantial
Equivalence:The Relieva Luma™ Sinus Illumination System is substantially
equivalent to the predicate device as confirmed through relevant
performance tests.

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1

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.

2

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

3

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)

Page of

(Posted November 13, 2003)

Division Sign-Division of Ophthalmic Ea Nose and Throat D

510(k) Number