(57 days)
Not Found
No
The summary describes a physical device (a spacer) and its function, with no mention of software, algorithms, or any terms related to AI/ML.
No.
Explanation: The device is used to maintain an opening post-surgery and prevent obstruction, which is a supportive function rather than directly treating a disease or condition. Its purpose is to facilitate healing and prevent complications, which aligns more with a device that provides temporary support or mechanical assistance rather than a therapeutic intervention in itself.
No
The device is described as a "postoperative spacer" used to "maintain an opening" and "prevent obstruction" in the frontal sinuses. This function is therapeutic and interventional, rather than diagnostic. There is no mention of assessing conditions, taking measurements for diagnosis, or providing diagnostic information.
No
The device description clearly indicates a physical "Frontal Sinus 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 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: The description clearly states the device is a "postoperative spacer to maintain an opening to the frontal sinuses." This is a physical device inserted into the body to serve a mechanical function.
- Intended Use: The intended use is to maintain an opening and prevent obstruction within the body after surgery. This is a therapeutic or supportive function, not a diagnostic test performed on a sample outside the body.
The device is a medical device, but it falls under the category of a surgical or implantable device (even if temporary), not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
KAM
Device Description
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.
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 Frontal Sinus Spacer met all performance acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sinus Spacer (K072891)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K08 35 74
Acclarent /
JAN 2 9 2009
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keri Yen
Sr. Regulatory Affairs Specialist
Phone: (650) 687-5874
Fax: (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 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. |
| 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. |
| Technological
Characteristics: | The Frontal Sinus Spacer is designed to be implanted into the frontal
sinuses and to maintain its position by a self-retention mechanism. |
| Performance Data: | The Frontal Sinus Spacer met all performance acceptance criteria. |
| Summary of Substantial
Equivalence: | The Frontal Sinus Spacer is substantially equivalent to the predicate
device as confirmed through relevant performance tests. |
.
1
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.
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,
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
3
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)