(161 days)
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.
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.
The provided document is a 510(k) Summary for a medical device called "Sinus Spacer". It is a regulatory submission to the FDA, and as such, it does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance in a clinical or scientific study. The document states in a general manner that "The Sinus Spacer met all performance acceptance criteria" and "The Sinus Spacer is substantially equivalent to the predicate devices as confirmed through relevant performance tests."
However, it does not provide the specific acceptance criteria, the detailed results from a study, or the methodology to fulfill the request. The 510(k) summary focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed independent clinical study with specific performance metrics.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated with quantifiable metrics. The document only states: "The Sinus Spacer met all performance acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no such test set or ground truth establishment is described for a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no such test set or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical "Sinus Spacer" and not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical "Sinus Spacer" and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no ground truth is described for a clinical study on this device. Performance tests mentioned are likely engineering/bench tests related to material properties, retention mechanism, etc., rather than clinical outcomes with a ground truth.
8. The sample size for the training set
- Not applicable as this is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable as this is a physical medical device, not a machine learning model requiring a training set.
Summary Table (based on available information):
| Criterion/Information | Description |
|---|---|
| Acceptance Criteria | Not explicitly stated in the document. The document only indicates: "The Sinus Spacer met all performance acceptance criteria." These likely refer to engineering or bench testing criteria for material properties, mechanical integrity, and retention, rather than clinical performance metrics. |
| Reported Device Performance | The document states: "The Sinus Spacer met all performance acceptance criteria." No specific performance metrics or results (e.g., retention force, biocompatibility test results, etc.) are provided in this summary. It's also mentioned that it "is substantially equivalent to the predicate devices as confirmed through relevant performance tests." |
| Sample size used for the test set and data provenance | Not specified. The "performance tests" mentioned are likely bench tests or in vitro studies, not human clinical trials with a test set in the conventional sense. |
| Number of experts used to establish ground truth & qualifications | Not applicable. No clinical ground truth establishment described. |
| Adjudication method for the test set | Not applicable. |
| MRMC comparative effectiveness study for human readers with/without AI assistance | Not applicable. The device is a physical spacer, not an AI or imaging-based diagnostic tool. |
| Standalone (algorithm only) performance study | Not applicable. The device is a physical spacer, not an algorithm. |
| Type of ground truth used | Not applicable. The "performance tests" likely used engineering measurements or material standards as their "ground truth" rather than clinical outcomes or pathology, which are typically associated with diagnostic or therapeutic efficacy studies. |
| Sample size for the training set | Not applicable. This is a physical medical device, not an AI/machine learning model. |
| How the ground truth for the training set was established | Not applicable. This is a physical medical device, not an AI/machine learning model. |
Study Context:
The document is a 510(k) premarket notification for regulatory clearance. For devices classified as Class I exempt that are substantially equivalent to existing predicates, the FDA often relies on bench testing, material characterization, and comparison to predicate devices, rather than extensive clinical efficacy studies with human subjects that establish "ground truth" in the way an AI diagnostic device would. The "performance data" mentioned would typically refer to non-clinical tests (e.g., biocompatibility, sterilization validation, mechanical strength, retention capability in an in vitro model).
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Sinus Spacer
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
|---|---|
| Contact Person: | Keri YenRegulatory Affairs SpecialistPhone: (650) 687-5874Fax: (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 theintended sinus not to exceed 14 days postoperatively. Thesubject device can be manually removed during an officefollow-up visit at any time. |
| Indications for Use: | The Sinus Spacer is indicated for use as a postoperative spacerto maintain an opening to the nasal sinuses within the first 14days following surgery. The Sinus Spacer also helps toprevent obstructions. |
| TechnologicalCharacteristics: | The Sinus Spacer is designed to be implanted into all sinusesand to maintain its position by a self-retention mechanism. |
| Performance Data: | The Sinus Spacer met all performance acceptance criteria. |
| Summary of SubstantialEquivalence: | The Sinus Spacer is substantially equivalent to the predicatedevices 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.
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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
§ 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.