(57 days)
The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
The Frontal Sinus Spacer is a device that maintains an opening at the frontal sinus for up to 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.
The provided document is a 510(k) summary for the Acclarent Relieva Stratus MicroFlow Spacer. However, it does not contain the detailed performance data or study information required to answer your specific questions about acceptance criteria and study design.
The document states:
- "The Frontal Sinus Spacer met all performance acceptance criteria."
- "The Frontal Sinus Spacer is substantially equivalent to the predicate device as confirmed through relevant performance tests."
This indicates that internal performance testing was conducted, and the device met the pre-defined criteria. However, the summary does not provide the actual acceptance criteria, the reported device performance metrics, or any details about the study design (e.g., sample size, ground truth, expert qualifications, adjudication methods, or a multi-reader multi-case comparative effectiveness study).
Therefore, I cannot populate the table or provide specific answers to questions 2 through 9 based solely on the provided text. To get that information, you would typically need to consult a more detailed document, such as the full 510(k) submission or a dedicated performance study report, which are not included here.
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K08 35 74
Acclarent /
JAN 2 9 2009
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
|---|---|
| Contact Person: | Keri YenSr. Regulatory Affairs SpecialistPhone: (650) 687-5874Fax: (650) 687-4449 |
| Date of Submission: | December 1, 2008 |
| Device Trade Name: | Relieva Stratus MicroFlow Spacer |
| Common Name: | Frontal Sinus Spacer |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 878.4800 |
| Classification Name: | Manual surgical instrument for general use |
| Product Code: | KAM |
| Predicate Device: | Sinus Spacer (K072891) |
| Device Description: | The Frontal Sinus Spacer is a device that maintains an opening at thefrontal sinus for up to 14 days postoperatively. The subject device canbe manually removed during an office follow-up visit at any time. |
| Indications for Use: | The MicroFlow Spacer (Frontal) is indicated for use as a postoperativespacer to maintain an opening to the frontal sinuses within the first 14days following surgery. The MicroFlow Spacer also helps to preventobstruction. |
| TechnologicalCharacteristics: | The Frontal Sinus Spacer is designed to be implanted into the frontalsinuses and to maintain its position by a self-retention mechanism. |
| Performance Data: | The Frontal Sinus Spacer met all performance acceptance criteria. |
| Summary of SubstantialEquivalence: | The Frontal Sinus Spacer is substantially equivalent to the predicatedevice as confirmed through relevant performance tests. |
.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, with three curved lines representing wings or arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2009
Acclarent, Inc. c/o Ms. Keri Yen Sr. Regulatory Affairs Specialist 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K083574
Trade/Device Name: Relieva Stratus MicroFlow Spacer / Frontal Sinus Spacer Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: KAM Dated: December 1, 2009 Received: December 3, 2009
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,
Mahina B. Esguerra, M.D.
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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K 085577
Acclarent /
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
KOB3574
Trade Name:
Relieva Stratus MicroFlow Spacer
Common Name:
Frontal Sinus Spacer
Indications For Use:
The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
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)
Daniel C. Cerpa
Division Sign Off
(Division Sign-Off) Division of Ophthalmic and Ear. Nose and Throat Devices
510(k) Number K083574
Page 1 of /
(Posted November 13, 2003)
§ 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.