(104 days)
Not Found
No
The 510(k) summary describes a physical device (a spacer) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a "postoperative spacer" that "maintains an opening" and "helps to prevent obstruction" in the sinuses, which are therapeutic actions.
No
Explanation: The device is described as a "postoperative spacer" used to maintain an opening in the sinuses and prevent obstruction after surgery. Its intended use is therapeutic (maintaining an opening and preventing obstruction), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly indicates a physical "spacer" that is manually removed, implying a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The MicroFlow Spacer is a physical device inserted into the sinuses to maintain an opening and prevent obstruction after surgery. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes a physical function within the body, not an analysis of samples taken from the body.
Therefore, the MicroFlow Spacer is a surgical/implantable device, not an IVD.
N/A
Intended Use / Indications for Use
The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
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.
Product codes (comma separated list FDA assigned to the subject device)
KAM
Device Description
The MicroFlow Spacer is a device that maintains an opening at the target sinus for up to 14 days postoperatively. There are two models of the MicroFlow Spacer: Ethmoid and Frontal. The modified device can be manually removed during an office follow-up visit at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ethmoid sinuses, 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 MicroFlow Spacer met all performance 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.
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
Aclarent
MAR - 3 2010
:
Krg3594
| APPENDIX A: 510(k) SUMMARY | |
|---|---|
| Sponsor/Submitter: | Acclarent, Inc. |
| 1525-B O'Brien Drive | |
| Menlo Park, California 94025 | |
| Contact Person: | Courtney Kalof |
| Regulatory Affairs Coordinator | |
| Phone: (650) 687-4473 | |
| Fax: (650) 687-4449 | |
| Date of Submission: | November 16, 2009 |
| Device Trade Name: | Relieva Stratus MicroFlow Spacer |
| Common Name: | MicroFlow Spacer |
| 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 (K083574) |
| Device Description: | The MicroFlow Spacer is a device that maintains an opening at the |
| target sinus for up to 14 days postoperatively. There are two models of | |
| the MicroFlow Spacer: Ethmoid and Frontal. The modified device can | |
| be manually removed during an office follow-up visit at any time. | |
| Indications for Use: | The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative |
| spacer to maintain an opening to the ethmoid sinuses within the first 14 | |
| days following surgery. The MicroFlow Spacer also helps to prevent | |
| obstruction. |
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. |
| Technological
Characteristics: | The MicroFlow Spacer is designed to be implanted into the frontal or
ethmoid sinuses and to maintain its position by a self-retention
mechanism. |
1
Image /page/1/Picture/0 description: The image shows the word "Acclarent" in a bold, sans-serif font. A curved line extends from the top right of the "t", arcing over the word and ending near the right side of the "t". The text is black and the background is white.
Performance Data:
The MicroFlow Spacer met all performance acceptance criteria.
Summary of Substantial Equivalence:
. .
The MicroFlow Spacer is substantially equivalent to the predicate device as confirmed through relevant performance tests.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
MAR 3 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Acclarent, Inc. c/o Ms. Courtney Kalof Regulatory Affairs Coordinator 1525-B O'Brien Dr. Meno Park, CA 94025
Re: K093594
Trade/Device Name: Relieva Stratus MicroFlow Spacer Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: KAM Dated: January 26, 2010 Received: January 27, 2010
Dear Ms. Kalof:
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. 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
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); 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 electronic product radiation control provisions (Sections 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/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Peter Schmidt
Malvina B. Eydelman. M.L Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Acclarént
APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K093594 |
|---|---|
| Trade Name: | Relieva Stratus MicroFlow Spacer |
| Common Name: | MicroFlow 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. |
| The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction. | |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | X |
| 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. Cupp
(Division Sign-Off)
Page i of /
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
:10(k) Number KD93594