RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) by ACCLARENT, INC.

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.

Device Description

The Relieva Stratus Pro MicroFlow Spacer (Frontal) is a device that maintains an opening at the target sinus for up to 14 days postoperatively. The device can be manually removed during an office follow-up visit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Relieva Stratus Pro MicroFlow Spacer (Frontal). It highlights the device's purpose, classification, and a summary of its performance data. However, the document does not contain the detailed information requested regarding the acceptance criteria, specific study design, sample sizes, ground truth establishment, or multi-reader multi-case studies as would be expected for an AI/ML powered device.

The information provided is typical for a Class I medical device (manual surgical instrument for general use) where equivalence to a predicate device is established through demonstrating compliance with recognized standards and basic performance requirements. This is not a submission for an AI/ML-powered device.

Therefore, I cannot populate the requested table and sections with the information about acceptance criteria and study data for an AI/ML device because the provided text pertains to a traditional, non-AI medical device.

The "Performance Data" section explicitly states: "The Relieva Stratus Pro MicroFlow Spacer (Frontal) met all performance acceptance criteria." It then lists criteria related to sterilization, sterility assurance level, non-pyrogenicity, ethylene oxide residuals, shelf life, and package integrity, all of which are standard for a physical medical implant, not an AI algorithm.

Here's a breakdown of why I cannot fulfill the request specifically for AI/ML device evaluation criteria based on the provided text:

No AI/ML Components: The device description ("maintains an opening at the target sinus for up to 14 days postoperatively") and its classification ("Manual surgical instrument for general use") clearly indicate it is a physical device, not an AI/ML algorithm.
Performance Data Type: The "Performance Data" section discusses:
- Sterilization (AAMI/ANSI/ISO 11135-1:2007)
- Sterility Assurance Level (10-6)
- Non-pyrogenicity (ANSI/AAMI ST72:2002)
- Ethylene oxide residuals (ISO 10993-7:2008)
- Shelf life (ASTM F1980-07)
- Package integrity (ASTM F88-07A, ISTA 2A-08, and ASTM F2096-04)
  These are all physical and biological safety standards, not metrics or studies related to AI/ML prediction or diagnostic performance.
Absence of AI-Specific Terminology: There is no mention of algorithms, models, datasets, training, testing, ground truth, accuracy, sensitivity, specificity, AUC, human readers, or any other terms associated with AI/ML device evaluation.

Conclusion: The provided document describes a Class I medical device in the context of a 510(k) submission, confirming its substantial equivalence to a predicate device based on standard performance tests for physical implants. It does not provide information relevant to the acceptance criteria or study design for an AI/ML-powered medical device.

Summary

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KII0687

OCT - 7 2011

8. 510(K) SUMMARY

Sponsor/Submitter:	Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025
Contact Person:	Dean KnightSenior Manager, Regulatory AffairsPhone: (650) 687-4807Fax: (650) 687-4449
Date of Submission:	March 9, 2011
Device Trade Name:	Relieva Stratus Pro MicroFlow Spacer (Frontal)
Common Name:	Sinus cannula
Device Classification:	Class I
Regulation Number:	21 CFR 878.4800
Classification Name:	Manual surgical instrument for general use
Product Code:	KAM
Predicate Device:	Relieva Stratus MicroFlow Spacer (K093594)
Device Description:	The Relieva Stratus Pro MicroFlow Spacer (Frontal) is a devicethat maintains an opening at the target sinus for up to 14 dayspostoperatively. The device can be manually removed during anoffice follow-up visit.
Indications for Use:	The MicroFlow Spacer is indicated for use as a postoperative spacerto maintain an opening to the frontal sinuses within the first 14 daysfollowing surgery. The MicroFlow Spacer also helps to preventobstruction.
TechnologicalCharacteristics:	The Relieva Stratus Pro MicroFlow Spacer (Frontal) is designed tobe implanted into the frontal sinuses and to maintain its position bya self-retention mechanism.The safety and effectiveness of injecting solutions other than salinesolution in the catheter have not been established.
Performance Data:	The Relieva Stratus Pro MicroFlow Spacer (Frontal) met allperformance acceptance criteria.The sterilization process is validated per AAMI/ANSI/ISO 11135-1: 2007. The device meets the requirements for a sterilityassurance level of 10-6.The device is non-pyrogenic per ANSI/AAMI ST72:2002.

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requirements.

Post-sterilization ethylene oxide residuals were tested and meet ISO 10993-7:2008 requirements.

Shelf life was established at 13 months per ASTM F1980-07 requirements. Package integrity at the end of the shelf life was established per ASTM F88-07A, ISTA 2A-08, and ASTM F2096-04 requirements.

Summary of Substantial Equivalence:

The Relieva Stratus Pro MicroFlow Spacer (Frontal) is substantially equivalent to the predicate device as confirmed through relevant performance tests.

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Public Health Service

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Acclarent, Inc. c/o Mr. Dean Knight Senior Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025

OCT - 7 200

Re: K110687

Trade/Device Name: Relieva Stratus Pro MicroFlow Spacer (Frontal) Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: KAM Dated: September 7, 2011 Received: September 9, 2011

Dear Mr. Knight:

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 (Act) that do trequire 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 misting and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Dean Knight

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 administred 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); medical device reporting (reporting of medical device related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the election in
radiation control provisions (Section (21 CFR Part 820); and if applicable, the elec radiation control provisions (21 CFR Part 820); and If applicable, the elections 531-542 of the Act.); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
go to http://www.fda.gov/AboutFDA/ContemOff. - (CDPMCF 1 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health s (CDRHCDRHCesuum 115809.htm for
note the regulation entitled "Michaeline base is a level se office of Compliance. Also, pleas note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of reference to premated notification" (21CFR Part
807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International only on tesponsibilities under the Act from the
(800) 638-2041 or (101) 796-7100 or at its June Assistance at its toll-free num (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

https://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Malvina R. Fudala, M.D.

Malvina B. Eydelman, Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K110687

Special 510(k) Premarket Notification Acclarent, Inc. March 2011

Page 13 of 50

7. STATEMENT OF INDICATIONS FOR USE

Indications for Use

510(k) Number (if known): KIID687

Device Name: Relieva Stratus Pro MicroFlow Spacer (Frontal) __________________________________________________________________________________________________________________

Indications for Use:

Prescription Use V (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel C. Clapp

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110687

Page 1 of 1

Regulation Number and Section

§ 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.