(210 days)
Not Found
No
The 510(k) summary describes a physical device (a spacer) and its performance characteristics related to material properties, sterilization, and shelf life. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is used to maintain an opening in the frontal sinuses post-surgery and prevent obstruction, which are actions that contribute to the healing process and improved patient outcome.
No
Explanation: The device is described as a postoperative spacer to maintain an opening and prevent obstruction, not to diagnose a condition.
No
The device description clearly indicates it is a physical spacer intended for surgical implantation, not a software product. The performance studies also focus on physical properties like sterilization, pyrogenicity, and shelf life.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the MicroFlow Spacer is a physical device intended to be placed within the frontal sinuses after surgery to maintain an opening and prevent obstruction. It is a physical implant/spacer, not a test performed on a sample.
The information provided describes a surgical device used for post-operative care, not a diagnostic test.
N/A
Intended Use / Indications for Use
The MicroFlow Spacer 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.
Product codes (comma separated list FDA assigned to the subject device)
KAM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal sinuses
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 Stratus Pro MicroFlow Spacer (Frontal) met all performance acceptance criteria. The sterilization process is validated per AAMI/ANSI/ISO 11135-1: 2007. The device meets the requirements for a sterility assurance level of 10-6. The device is non-pyrogenic per ANSI/AAMI ST72:2002 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.
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 Stratus MicroFlow Spacer (K093594)
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.
0
KII0687
OCT - 7 2011
8. 510(K) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dean Knight
Senior Manager, Regulatory Affairs
Phone: (650) 687-4807
Fax: (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 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. |
| Indications for Use: | The MicroFlow Spacer 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. |
| Technological
Characteristics: | The Relieva Stratus Pro MicroFlow Spacer (Frontal) is designed to
be implanted into the frontal sinuses and to maintain its position by
a self-retention mechanism.
The safety and effectiveness of injecting solutions other than saline
solution in the catheter have not been established. |
| Performance Data: | The Relieva Stratus Pro MicroFlow Spacer (Frontal) met all
performance acceptance criteria.
The sterilization process is validated per AAMI/ANSI/ISO 11135-
1: 2007. The device meets the requirements for a sterility
assurance level of 10-6.
The device is non-pyrogenic per ANSI/AAMI ST72:2002. |
1
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.
2
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.
3
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
4
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:
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 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
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