(25 days)
No
The summary describes a mechanical device used for calibration and guidance, with no mention of AI/ML, image processing, or data-driven algorithms.
No
The device is used to access the sinus space for diagnostic and therapeutic procedures, but it does not perform the therapeutic action itself. It acts as a guide or adapter for other instruments.
No
The device is described as providing a means to access the sinus space for diagnostic and therapeutic procedures, but its primary function as described in the Device Description section is to guide and calibrate a catheter for trajectory, not to perform diagnosis itself.
No
The device description explicitly mentions physical components: "Sinus Guide Adapter," "Calibration Device," and "Sinus Guide Catheter." These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a means to access the sinus space for diagnostic and therapeutic procedures." This describes a device used during a procedure on a patient, not a device used to test samples outside the body.
- Device Description: The description details components used to guide a catheter and calibrate its position within the sinus space. This is consistent with a surgical or procedural device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to facilitate access and guidance within the body.
N/A
Intended Use / Indications for Use
The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
Product codes
KAM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus space
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
The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter and Calibration Device met all performance testing acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Sinus Guide Catheter (K043445)
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
K0600974
Image /page/0/Picture/1 description: The image shows the word "Acclarent" in a bold, sans-serif font. There is a curved line above the "t" in "Acclarent". The word and curved line are black against a white background.
: 上一篇:
Sinus Guide Adapter and Calibration Device
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Special 510(k): Device Modification
CONFIDENTIAL
| 5/5/06 | ||
|---|---|---|
| APPENDIX A: 510(k) SUMMARY | ||
| Sponsor/Submitter: | Acclarent, Inc. | |
| 1525-B O'Brien Drive | ||
| Menlo Park, California 94025 | ||
| Contact Person: | Su-Mien Chong | |
| Vice President, Clinical/Quality/Regulatory | ||
| Phone: (650) 704-1632 | ||
| Fax: (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 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. | ||
| Indications for Use: | The Sinus Guide Adapter and Calibration Device are intended to provide a | |
| means to access the sinus space for diagnostic and therapeutic procedures. | ||
| Technological | ||
| Characteristics | The Sinus Guide Adapter and Calibration Device are accessory devices to the | |
| Sinus Guide Catheter. The accessory devices enable navigation capability for | ||
| the Sinus Guide Catheter, if desired. | ||
| Performance Data | The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter and | |
| Calibration Device met all performance testing acceptance criteria. | ||
| Summary of | ||
| Substantial | ||
| Equivalence: | The Sinus Guide Adapter and Calibration Device are substantially equivalent to | |
| the predicate device as confirmed through relevant performance tests. |
1
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.
2
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
3
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