(89 days)
The Iontophoresis System with Earset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
The Acclarent Iontophoresis System with Earset (IPSES) is a single-use device that employs electric current to transport drug solution, salts, or ions into the ear, including the tympanic membrane. The TULA Iontophoresis System consists of three components, namely an Iontophoresis Control Unit, Iontophoresis Earsets and a Return Electrode Patch. Accessories to the IPSES include a Syringe and Earset Sizers. All components of the IPSES are provided non-sterile and no sterilization is required.
This document is a 510(k) summary for the Acclarent TULA® Iontophoresis System with Earset. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of clinical performance metrics. Therefore, many of the requested details regarding clinical study design, sample sizes, expert involvement, and ground truth are not present in this type of regulatory submission.
However, I can extract the available information regarding performance data and acceptance criteria based on bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily describes bench verification testing performed to demonstrate substantial equivalence to a predicate device, focusing on design inputs and intended performance characteristics. Specific quantitative acceptance criteria are not explicitly listed in a table format, but the performance data indicates that the device met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets design inputs and intended performance characteristics | Bench verification testing conducted; meets design inputs and intended performance characteristics. |
| System functionality (e.g., electrical current delivery) | System test conducted. |
| Ear canal pressure and leak integrity | Ear canal pressure and leak test conducted. |
| Fill system burst capacity | Fill system burst test conducted. |
| Secure attachment of ear plug (peel force) | Plug peel force test conducted. |
| Initial adhesion of ear plug to patient (tack force) | Tack force test conducted. |
| Biocompatibility of materials | Biocompatibility tests conducted. |
| Compliance with electrical safety standards (IEC 60601-1, IEC 60601-1-2) | Electrical testing demonstrated that the subject device (IPSES) meets all applicable requirements of IEC 60601-1 and IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench verification testing, not a clinical trial. Therefore, information regarding a "test set" in the context of patient data, sample sizes for such a set, or data provenance (country of origin, retrospective/prospective) is not provided and is not applicable to the reported testing. The tests would involve physical device units rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
As the provided text focuses on bench testing and substantial equivalence, there is no mention of "experts" being used to establish "ground truth" in a clinical sense. The testing performed would have been evaluated against engineering specifications and industry standards by technical personnel.
4. Adjudication Method
Not applicable, as this refers to adjudication of clinical data, which is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The document describes a 510(k) submission for a medical device (iontophoresis system) based on substantial equivalence. This type of submission typically involves bench testing and comparison to a predicate device, not MRMC studies comparing human readers' performance with and without AI assistance.
6. Standalone Performance Study
The document describes bench verification testing of the device's functional and safety characteristics. This can be considered a form of standalone performance evaluation for the device itself (e.g., electrical safety, mechanical integrity). However, it is not a "standalone algorithm performance" in the context of an AI/ML device, as this is a physical medical device. The "Performance Data" section lists various tests performed on the device to ensure it meets design inputs and standards.
7. Type of Ground Truth Used
For the bench testing described, the "ground truth" would be established by:
- Engineering specifications and design inputs: The device's performance was compared against predetermined technical requirements.
- Industry standards: Compliance with standards like IEC 60601-1 and IEC 60601-1-2 served as the "ground truth" for electrical safety.
- Predicate device characteristics: Performance was also implicitly compared to the characteristics of the predicate device to demonstrate substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This document does not describe an AI/ML device, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model described in this document.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Acclarent, Inc. Pavan Sethi, PhD Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K150453
Trade/Device Name: Tula Iontophoresis System with Earset Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class III Product Code: EGJ Dated: April 21, 2015 Received: April 22, 2015
Dear Dr. Sethi:
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.
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 device
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related 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.
Our substantially equivalent decision does not apply to the drugs that you will label or promote for use with your device. Therefore, you may neither label nor promote your device for use with specific drugs, nor package drugs with your device prior to FDA having approved the drugs for iontophoretic administration. For information on the requirements for marketing new drugs, you may contact:
Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857
As you are aware, there are concerns relating to the fact that no drug is currently labeled for administration via an iontophoresis device. The Agency currently is evaluating this public health concern regarding the safety and effectiveness of this route of administration of drugs, and in the near future will inform manufacturers of certain additional steps the Agency believes are necessary to address this concern.
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 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.
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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,
Felipe Aguel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150453
Device Name
TULA® Iontophoresis System with Earset
Indications for Use (Describe)
The Iontophoresis System with Earset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
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) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
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TULA Iontophoresis System with Earset
510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
|---|---|
| Contact Person: | Pavan Sethi, Ph.D.Manager, Regulatory AffairsPhone: (650) 687-5413Fax: (650) 687-4847 |
| Date of Submission: | February 19, 2015 |
| Device Trade Name: | TULA® Iontophoresis System |
| Common Name: | Iontophoresis System with Earset |
| Device Classification: | Class III |
| Regulation Number: | 21 CFR 890.5525 |
| Classification Name: | Device, Iontophoresis, Other Purposes |
| Product Code: | EGJ |
| Predicate Device: | Iontophoresis System with Headset or IPSHS (K110636) manufactured byAcclarent |
| Device Description: | The Acclarent Iontophoresis System with Earset (IPSES) is a single-usedevice that employs electric current to transport drug solution, salts, or ionsinto the ear, including the tympanic membrane. The TULA lontophoresisSystem consists of three components, namely an Iontophoresis Control Unit,Iontophoresis Earsets and a Return Electrode Patch. Accessories to the IPSESinclude a Syringe and Earset Sizers. All components of the IPSES are providednon-sterile and no sterilization is required. |
| Indications for Use: | The Iontophoresis System with Earset is indicated for the administration ofdrug solution, salts, or ions into the ear, including the tympanic membrane, formedical purposes. |
| TechnologicalCharacteristics: | IPSES delivers an electrical current to the ear. The electrical current transportsdrug solution, salts, or ions into the ear, including the tympanic membrane. Thesubject device is identical to the predicate device in method of operation andintended use. The Iontophoresis process and the components controlling itincluding Control Unit, Integrated Ear Electrode and Return Electrode Patchare unchanged between the subject and predicate device. The main differencesin technological characteristics include, modification of the mechanism to |
| retain the ear plug in the external ear canal and integration of ear plugs into thedesign of the earset instead of being a separate accessory in the predicateHeadset device. In the predicate device, the ear plug is attached to the Headsetand retains the fluid (drug solution, salts, or ions) within the ear canal byforming a seal. The modified device integrates this ear plug into a smaller sizedEarset to achieve an analogous seal. The predicate device uses a frame tomaintain the Headset in position and a spring to hold the ear plug in the earcanal, whereas the modified subject device uses a small amount of softpressure sensitive adhesive (PSA) to secure the ear plug to the patient. Thesedifferences in technological characteristics do not raise different questions ofsafety and effectiveness than the predicate and do not render this device NotSubstantially Equivalent (NSE). | |
| Performance Data: | Bench verification testing was conducted to verify that the modified devicemeets the design inputs and intended performance characteristics. The testingincluded system test, ear canal pressure and leak test, fill system burst test,plug peel force test, tack force test, and biocompatibility tests. |
| Electrical testing demonstrated that the subject device IPSES meets allapplicable requirements of the standards of IEC 60601-1 and IEC 60601-1-2. | |
| Summary ofSubstantialEquivalence: | The subject device IPSES is substantially equivalent to the predicate device inindication for use, performance, fundamental scientific technology, safety andeffectiveness. |
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§ 890.5525 Iontophoresis device.
(a)
Iontophoresis device intended for certain specified uses —(1)Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.(2)
Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:
Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.