(161 days)
Not Found
No
The summary describes a physical device (a spacer/stent) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a "postoperative spacer to maintain an opening" and to "prevent obstructions" for up to 14 days following surgery. It is manually removable and does not claim to treat a disease, disorder, or injury.
No
The device is described as a "Sinus Spacer" intended to maintain an opening in the nasal sinuses post-surgery and prevent obstructions. Its function is to provide physical support and spacing, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly indicates a physical "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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Sinus Spacer Function: The description clearly states the Sinus Spacer is used within the nasal sinuses post-surgery to maintain an opening and prevent obstructions. It is a physical device placed inside the body.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on biological samples or providing diagnostic information. Its function is purely mechanical and structural.
Therefore, the Sinus Spacer falls under the category of a surgical or implantable device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the nasal sinuses within the first 14 days following surgery. The Sinus Spacer also helps to prevent obstructions.
Product codes
KAM
Device Description
The Sinus Spacer is a device that maintains an opening at the intended sinus not to exceed 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
nasal 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K062458, K951066, K050340, K912418
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
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Sinus Spacer
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keri Yen
Regulatory Affairs Specialist
Phone: (650) 687-5874
Fax: (650) 687-4449 |
| Date of Submission: | October 9, 2007 |
| Device Trade Name: | TBD |
| Common Name: | Sinus Spacer |
| Device Classification: | Class I exempt |
| Regulation Number: | 21 CFR 878.4800 |
| Classification Name: | Manual surgical instrument for general use |
| Product Code: | KAM |
| Predicate Devices: | Ethmoid Sinus Spacer (K062458)
Rains Frontal Sinus Stent (K951066)
Micromedics, Inc. Sphenoid Sinus Stent (K050340)
Shikani Middle Meatal Antrostomy Stent (K912418) |
| Device Description: | The Sinus Spacer is a device that maintains an opening at the
intended sinus not to exceed 14 days postoperatively. The
subject device can be manually removed during an office
follow-up visit at any time. |
| Indications for Use: | The Sinus Spacer is indicated for use as a postoperative spacer
to maintain an opening to the nasal sinuses within the first 14
days following surgery. The Sinus Spacer also helps to
prevent obstructions. |
| Technological
Characteristics: | The Sinus Spacer is designed to be implanted into all sinuses
and to maintain its position by a self-retention mechanism. |
| Performance Data: | The Sinus Spacer met all performance acceptance criteria. |
| Summary of Substantial
Equivalence: | The Sinus Spacer is substantially equivalent to the predicate
devices as confirmed through relevant performance tests. |
| | MAR 19 2008 |
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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 features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure. The logo is printed in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2008
Acclarent, Inc. c/o Keri Yen Regulatory Affairs Specialist 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K072891
Trade/Device Name: Sinus Spacer Regulation Number: 21 CFR 874.4800 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: KAM Dated: March 7, 2008 Received: March 10, 2008
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. Iisting 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,
Malvina B. Egleston, wid
Malvina B. Eydelman, M. 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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Sinus Spacer
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Trade Name:
To be determined
Common Name:
Sinus Spacer
Indications For Use:
The Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the nasal sinuses within the first 14 days following surgery. The Sinus Spacer also helps to prevent obstructions.
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)
Karen Baker
n Sian-C Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number