(71 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is used to inflate, deflate, and monitor pressure in balloon catheters, which are the therapeutic devices used in sinus procedures. The inflation device itself merely controls the therapeutic device.
No
The device is an instrument used to inflate, deflate, and monitor pressure in balloon catheters during sinus procedures. It does not diagnose medical conditions. Its purpose is procedural, not diagnostic.
No
The device description explicitly details physical components such as a pressure gauge, syringe barrel, piston mechanism, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, the ACCLARENT® SE Inflation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures." This describes a device used in vivo (within the body) for a surgical or procedural purpose, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces its function in inflating and deflating balloons within the body during sinus procedures. It mentions a pressure gauge and syringe barrel, which are consistent with a device used for manipulating pressure and fluid in a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect diseases, or provide diagnostic information based on in vitro testing.
Therefore, the ACCLARENT® SE Inflation Device is a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACCLARENT® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures.
Product codes (comma separated list FDA assigned to the subject device)
LRC
Device Description
The ACCLARENT SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used during sinus procedures. When used in a Balloon Sinuplasty dilation procedure, the inflation device enables the user to inflate the sinus balloon catheter, monitor the pressure within the balloon, and deflate the balloon. The device has a pressure gauge that indicates the atmospheric pressure at which the attached balloon is inflated, a high pressure syringe barrel that indicates the amount of fluid in the chamber, a mechanism to lock/unlock the piston, an ergonomic piston handle, and high pressure tubing used to attach the inflation device to the balloon catheters. The ACCLARENT SE Inflation Device should only be used with Acclarent Sinus Balloon Catheters with balloon sizes less than or equal to 7mmx24mm. Consult the individual Acclarent sinus balloon catheter carton labels for balloon size information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus
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)
Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, and reliability following three years of simulated accelerated aging.
Biocompatibility testing was performed for the ACCLARENT SE Inflation Device in accordance with EN ISO 10993-1: 2009. Biocompatibility testing for the SE Inflation Device included: Intracutaneous Reactivity (ISO 10993-10:2013, Pass), Sensitization (ISO 10993-10:2013, Pass), In Vitro Cytotoxicity (ISO 10993-5:2009, Pass), Systemic Toxicity (ISO 10993-11:2009, Pass).
Biocompatibility data indicates that the likelihood of a toxic biologic effect from the SE Inflation Device is negligible. Additionally, the ACCLARENT SE Inflation Device is determined to have met the requirements of EN ISO 10993-1 and FDA General Program Memorandum #G95-1, and is therefore considered safe from a biocompatibility perspective.
The sterilization process was validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 100. Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements.
The subject device is not tested nor labeled as "non-pyrogenic". Packaging shelf life was established at three years via accelerated aging per ASTM F 1980-07. Clinical data was not necessary to establish the safety and efficacy of the ACCLARENT SE Inflation Device. The performance data demonstrates that the subject device performs as intended. The performance data demonstrate that the device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(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 § 874.9.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized representation of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a stacked formation, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2015
Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K150172
Trade/Device Name: Acclarent SE Inflation Device Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: March 12, 2015 Received: March 13, 2015
Dear Mr. Garvey:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for 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
2
Indications for Use
510(k) Number (if known) K150172
Device Name ACCLARENT SE Inflation Device
Indications for Use (Describe)
The ACCLARENT® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the word "Acclarent" in black font. The last few letters of the word are in purple font. There is a purple arc above the last few letters of the word.
Acclarent SE Inflation Device
Special 510(k) Premarket Notification -
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Patrick Garvey II
Sr. Manager, Regulatory Affairs
Phone: (650) 687-4807
Fax: (650) 687-4847 |
| Date of Submission: | March 12, 2015 |
| Device Trade Name: | ACCLARENT SE Inflation Device |
| Common Name: | Balloon Inflation Device |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 874.4420 |
| Classification Name: | Ear, nose, and throat manual surgical instrument |
| Product Code: | LRC |
| Predicate Devices: | Acclarent Balloon Inflation Device (K052198) |
| Device Description: | The ACCLARENT SE Inflation Device is an instrument intended to inflate,
deflate and monitor pressure in balloon catheters used during sinus procedures. |
| | When used in a Balloon Sinuplasty dilation procedure, the inflation device
enables the user to inflate the sinus balloon catheter, monitor the pressure
within the balloon, and deflate the balloon. |
| | The device has a pressure gauge that indicates the atmospheric pressure at
which the attached balloon is inflated, a high pressure syringe barrel that
indicates the amount of fluid in the chamber, a mechanism to lock/unlock the
piston, an ergonomic piston handle, and high pressure tubing used to attach the
inflation device to the balloon catheters. The ACCLARENT SE Inflation
Device should only be used with Acclarent Sinus Balloon Catheters with
balloon sizes less than or equal to 7mmx24mm. Consult the individual
Acclarent sinus balloon catheter carton labels for balloon size information. |
| Indications for Use: | The Acclarent® SE Inflation Device is an instrument intended to inflate, deflate
and monitor pressure in balloon catheters used sinus procedures. |
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Image /page/4/Picture/0 description: The image contains the word "Acclarent" in a bold, sans-serif font. The word is black, except for the tail of the "t", which is purple and extends into a curved shape above the word. The logo appears to be for the company Acclarent.
Acclarent SE Inflation Device
Technological Characteristics:
| Attribute | Predicate Device
Acclarent Balloon
Inflation Device | Subject Device
ACCLARENT SE
Inflation Device |
|---------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------|
| 510(k) number | K052198 | This Application |
| Model Number | BID30 | SE Inflation Device |
| Rigidity | Rigid | Same |
| Pressure Gauge | Values Displayed in
atmospheres (atm) &
Pounds per Square in
(PSI) | Values Displayed in
atmospheres (atm) only |
| Length
(Plunger not extended) | 8.1" | 8.8" |
| Length
(Plunger extended) | 11.3" | 11.1" |
| Device Diameter (at
hand position) | 1.0 inch | 1.3 inches |
| Flexible reinforced
high pressure tubing | Yes | Same |
| Syringe capacity | 20cc | 7cc |
| Luminescent dial | Yes | Yes |
Performance Data:
Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, and reliability following three years of simulated accelerated aging.
Biocompatibility testing was performed for the ACCLARENT SE Inflation Device in accordance with EN ISO 10993-1: 2009. Biocompatibility testing for the SE Inflation Device included:
| Test | Test Standard | Results |
|---|---|---|
| Intracutaneous | ||
| Reactivity | ISO 10993-10:2013 | Pass |
| Sensitization | ISO 10993-10:2013 | Pass |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Pass |
| Systemic Toxicity | ISO 10993-11:2009 | Pass |
Biocompatibility data indicates that the likelihood of a toxic biologic effect from the SE Inflation Device is negligible. Additionally, the ACCLARENT SE Inflation Device is determined to have met the requirements of EN ISO 10993-1 and FDA General Program Memorandum #G95-1, and is therefore considered safe from a biocompatibility perspective.
The sterilization process was validated per AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 100. Testing of ethylene oxide residuals met ISO 10993-7:2008 requirements.
The subject device is not tested nor labeled as "non-pyrogenic". Packaging shelf life was established at three years via accelerated aging per ASTM F 1980-07. Clinical data was not necessary to establish the safety and efficacy
5
Image /page/5/Picture/0 description: The image shows the word "Acclarent" in black font. There is a purple curved line above the word that starts at the end of the word and extends to the right. The font is sans-serif and the word is slightly italicized.
Acclarent SE Inflation Device
Special 510(k) Premarket Notification
of the ACCLARENT SE Inflation Device. The performance data demonstrates that the subject device performs as intended. The performance data demonstrate that the device performs as intended.
Summary of Substantial Equivalence:
The ACCLARENT SE Inflation Device is substantially equivalent to the predicate device.