(25 days)
The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the InstaTrak Receiver. The Sinus Guide Adapter is used in conjunction with a Calibration Device that is compatible with the InstaTrak Navigation system. The Calibration Device is used to calibrate the tip position and the trajectory line of the Sinus Guide Catheter. Once calibrated, the Calibration Device is removed.
The Acclarent ReliENT™ Navigation Device is an accessory to the Sinus Guide Catheter, enabling navigation capability for diagnostic and therapeutic procedures in the sinus space.
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter and Calibration Device met all performance testing acceptance criteria." However, specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) and their corresponding reported device performance values are not detailed in the provided text. The submission focuses on substantial equivalence based on meeting all general performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All performance testing criteria | Met all criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly refers to "performance testing" being conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information about the number of experts, their qualifications, or how ground truth was established for the specific performance tests.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No effect size of human readers improving with AI vs. without AI assistance is provided, as this device does not appear to involve AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an AI algorithm but a physical accessory for a navigation system. Therefore, a standalone algorithm-only performance study would not be applicable. The performance testing would relate to the physical and functional aspects of the adapter and calibration device.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance testing. Given the nature of a navigation device accessory, the ground truth would likely involve physical measurements and system accuracy assessments against known standards or reference points. It would not typically involve expert consensus, pathology, or outcomes data in the same way an image analysis algorithm would.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a physical medical device (an accessory for a navigation system), not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML algorithm, there is no training set or ground truth establishment relevant to AI model training.
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K0600974
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: 上一篇:
Sinus Guide Adapter and Calibration Device
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Special 510(k): Device Modification
CONFIDENTIAL
| 5/5/06 | ||
|---|---|---|
| APPENDIX A: 510(k) SUMMARY | ||
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 | |
| Contact Person: | Su-Mien ChongVice President, Clinical/Quality/RegulatoryPhone: (650) 704-1632Fax: (650) 687-5889 | |
| Date of Submission: | April 6, 2006 | |
| Device Trade Name: | ReliENT TM Navigation Device | |
| Common Name: | Sinus Guide Adapter and Calibration Device | |
| Device Classification: | Class 1 | |
| Regulation Number: | 21 CFR 874.4420 | |
| Classification Name: | ENT Manual Surgical Instrument | |
| Product Code: | KAM | |
| Predicate Device: | Sinus Guide Catheter (K043445) | |
| Device Description: | The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and theInstaTrak Receiver. | |
| The Sinus Guide Adapter is used in conjunction with a Calibration Device thatis compatible with the InstaTrak Navigation system. The Calibration Device isused to calibrate the tip position and the trajectory line of the Sinus GuideCatheter. Once calibrated, the Calibration Device is removed. | ||
| Indications for Use: | The Sinus Guide Adapter and Calibration Device are intended to provide ameans to access the sinus space for diagnostic and therapeutic procedures. | |
| TechnologicalCharacteristics | The Sinus Guide Adapter and Calibration Device are accessory devices to theSinus Guide Catheter. The accessory devices enable navigation capability forthe Sinus Guide Catheter, if desired. | |
| Performance Data | The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter andCalibration Device met all performance testing acceptance criteria. | |
| Summary ofSubstantialEquivalence: | The Sinus Guide Adapter and Calibration Device are substantially equivalent tothe predicate device as confirmed through relevant performance tests. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center resembles a stylized eagle or bird with outstretched wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2006
Acclarent, Inc. c/o Ms. Su-Mien Chong 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K060974
Trade/Device Name: ReliENT™ Navigation Device Regulation Number: 21 CFR 874.4420 Regulation Name: ENT Manual Surgical Instrument Regulatory Class: Class I Product Code: KAM Dated: April 19, 2006 Received: April 20, 2006
Dear Ms. Chong:
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.
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Page 2 - Ms. Su-Mien Chong
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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance al its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.himi.
Sincerely yours,
M.B. Egelston - 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
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Acclarént /
Special 510(k): Device Modification CONFIDENTIAL
APPENDIX B: INDICATIONS FOR USE STATEMENT
KO 60974 510(k) Number (if known):
Sinus Guide Adapter and Calibration Device
Trade Name: ReliENT™ Navigation Device
Sinus Guide Adapter and Calibration Device Common Name:
The Sinus Guide Adapter and Calibration Device are intended to Indications For Use: provide a means to access the sinus space for diagnostic and therapeutic procedures.
Prescription Use (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)
Page of of
(Posted November 13, 2003)
insion Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
Rose and Throat Devices
:10(k) Number K060924
§ 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.