(225 days)
Not Found
No
The device description and intended use indicate a simple mechanical actuator for dispensing medication. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is for dispensing medication, not for providing therapy itself. The text explicitly states it functions as a "general purpose actuator for dispensing prescribed aerosolized medication".
No
Explanation: The device is described as a "single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit". It functions as a connector and actuator for medication delivery, not for diagnosing any condition.
No
The device is described as a "breathing circuit connector" and "general purpose actuators" for dispensing medication, which are physical hardware components. There is no mention of software as the primary or sole function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "breathing circuit connector that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit."
- Intended Use: The intended use is to deliver medication to a patient on a breathing circuit.
The device's function and intended use are related to drug delivery and respiratory support, not to performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.
Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.
Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.
Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.
Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.
Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.
Product codes
CAF
Device Description
Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
as prescribed by a physician or other licensed health care practitioner.
short and long term critical care environments.
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)
Biocompatibility: There are no direct patient contacting parts to this device. The patient contact is External Communicating, Tissue, Long Term (> 30 d). A thorough toxicological assessment has been written on the data from the biocompatibility tests. The assessment supports substantial equivalence and biological safety for the intended device population.
No animal or clinical testing was necessary for evaluation of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
June 18, 2024
Thayer Medical Corporation % Amy Fowler Regulatory Counsel Pathmaker FDA Law, PLLC 1415 Lilac Dr N Suite 270 Minneapolis, Minnesota 55422
Re: K233553
Trade/Device Name: MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 17, 2024 Received: May 20, 2024
Dear Amy Fowler:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and
2
Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233553
Device Name
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
Indications for Use (Describe)
Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.
Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.
Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.
Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.
Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.
Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
Image /page/5/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a blue square with white circles inside, arranged in a pattern that resembles a dome or arch. Above the square, there are several black dots arranged in a curved line, creating a visual effect similar to a dotted line or a series of points. Below the square, the words "THAYER" and "MEDICAL" are stacked on top of each other in a bold, sans-serif font.
Date Prepared: June 17, 2024
SUBMITTER:
| Name: | Thayer Medical Corporation |
|---|---|
| Address: | 4575 South Palo Verde Road |
| Tucson, AZ 85714-1961 USA | |
| Telephone: | 520-790-5393 |
| FAX: | 520-790-5854 |
| Contact Person: | Amy Fowler, Pathmaker FDA Law |
| 1415 Lilac Dr N Suite 270 | |
| Minneapolis, MN 55422 | |
| fowler@pathmakerlaw.com | |
| 612-356-9653 |
SPONSOR CONTACT:
Jim Strickland, CEO regulatory@thayermedical.com Jim.strickland@thayermedical.com 520-790-5393 520-790-5854
1543A Dual Spray MDI Adapter
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A,
FAX:
Telephone:
NAME OF DEVICE:
Trade Name / Device Name:
Common / Usual Name:
CLASSIFICATION:
| Regulation Name: | Nebulizer |
|---|---|
| Regulation Number: | 21 CFR 868.5630 |
| Classification Panel: | Anesthesiology |
DEVICE DESCRIPTION:
Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.
Actuator
6
Image /page/6/Picture/0 description: The image is a logo for Thayer Medical. The logo features the words "THAYER MEDICAL" in bold, black, sans-serif font, stacked on top of each other. Above the text is a blue square filled with white circles of varying sizes, arranged in rows. Above the blue square are three rows of black dots, decreasing in number from top to bottom, creating a visual effect of radiating outward.
INDICATIONS FOR USE:
Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.
Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.
Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.
Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.
Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.
Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.
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Image /page/7/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of the words "THAYER MEDICAL" in a bold, sans-serif font, with "THAYER" stacked on top of "MEDICAL". Above the text is a blue square with a pattern of white circles inside, resembling a stylized lung or a cluster of cells. Above the blue square is a series of black dots arranged in an arc, creating a visual effect similar to a shadow or a gradient.
Thayer Medical Corporation 4575 South Palo Verde Road Tucson, Arizona 85714-1961 USA
PREDICATE DEVICES:
| 510(k) Number | Manufacturer | Trade Name | Product Code |
|---|---|---|---|
| K102658 | Thayer Medical | ||
| Corporation | MiniSpacer® Dual-Spray | ||
| MDI Adapter | CAF | ||
| K111570 | Thayer Medical | ||
| Corporation | MiniSpacer® Dual-Spray | ||
| MDI Adapter | |||
| Counter Incrementing | CAF |
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Image /page/8/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a blue square with white circles inside, arranged in a semi-circular pattern. Above the square are several black dots, also arranged in a semi-circular pattern. Below the square, the words "THAYER MEDICAL" are written in a bold, sans-serif font, with "THAYER" on top of "MEDICAL".
DISCUSSION OF SIMILARITIES AND DIFFERENCES BETWEEN THE SUBJECT AND PREDICATE DEVICES:
| Subject Device | K102658 | K111570 | |
|---|---|---|---|
| Common Name | Actuator | Actuator | Actuator |
| Classification Name | Nebulizer | Nebulizer | Nebulizer |
| Regulation | 21 CFR 868.5630 | 21 CFR 868.5630 | 21 CFR 868.5630 |
| Single Patient Use | Yes | Yes | Yes |
| Prescription Device | Yes | Yes | Yes |
| Subject Device | K102658 | K111570 | |
|---|---|---|---|
| Comparison of | |||
| Intended Use/ | |||
| Indications for Use | The Dual Spray | ||
| MiniSpacer® MDI | |||
| adapter is a single | |||
| patient, disposable | |||
| device for dispensing | |||
| pressurized metered | |||
| dose inhaler (pMDI) | |||
| medication into a | |||
| breathing circuit, as | |||
| prescribed by a | |||
| physician or other | |||
| licensed health care | |||
| practitioner. | The Dual Spray | ||
| MiniSpacer® MDI | |||
| adapter is a single | |||
| patient, disposable | |||
| device for dispensing | |||
| pressurized metered | |||
| dose inhaler (pMDI) | |||
| medication into a | |||
| breathing circuit, as | |||
| prescribed by a | |||
| physician or other | |||
| licensed health care | |||
| practitioner. | The MINISPACER® | ||
| 1024A, 1025A and | |||
| 1543A adapters are | |||
| single patient, | |||
| disposable devices for | |||
| dispensing pressurized | |||
| metered dose inhaler | |||
| (pMDI) medication into | |||
| a breathing circuit, as | |||
| prescribed by a | |||
| physician or other | |||
| licensed health care | |||
| practitioner. | |||
| The device is indicated | |||
| for patients on a | |||
| breathing circuit, for | |||
| whom aerosol | |||
| medication has been | |||
| prescribed, in short | |||
| term and long term | |||
| critical care | |||
| environments. | The device is indicated | ||
| for patients on a | |||
| breathing circuit, for | |||
| whom aerosol | |||
| medication has been | |||
| prescribed, in short | |||
| term and long term | |||
| critical care | |||
| environments. | The MINISPACER® | ||
| 1024A, 1025A and | |||
| 1543A adapters are | |||
| indicated for patients | |||
| on a breathing circuit, | |||
| for whom aerosol | |||
| medication has been | |||
| prescribed, in short | |||
| and long term critical | |||
| care environments. | |||
| The device is intended | |||
| for sale by or on the | |||
| order of a physician. | The device is intended | ||
| for sale by or on the | |||
| order of a physician. |
9
Image /page/9/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a blue square with white circles inside, arranged in a pattern that resembles a cloud or a cluster. Above the square, there are several rows of black dots, also arranged in a cloud-like pattern. Below the square, the words "THAYER MEDICAL" are printed in bold, black letters.
| Subject Device | K102658 | K111570 | |
|---|---|---|---|
| Materials, Body | Modified SBC | Legacy SBC | Legacy SBC |
| Materials, Actuator | ABS | ABS | ABS |
| Materials, Cap | SEBS | LDPE | SEBS |
| Dimensions | Same | Same | Same |
| Nozzle Design | Dual spray orifice | Dual spray orifice | Dual spray orifice |
| Non-sterile | Yes | Yes | Yes |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
SUMMARY OF PERFORMANCE TESTING:
Biocompatibility: There are no direct patient contacting parts to this device. The patient contact is External Communicating, Tissue, Long Term (> 30 d). A thorough toxicological assessment has been written on the data from the biocompatibility tests. The assessment supports substantial equivalence and biological safety for the intended device population.
No animal or clinical testing was necessary for evaluation of substantial equivalence.
SUBSTANTIAL EQUIVALENCE CONCLUSION:
Based upon the above comparisons, the subject device is substantially equivalent to the predicate devices. The only difference is the modification to the resin for the body, and the toxicological testing and risk assessment support that the subject device is substantially equivalent to the predicate(s). The information submitted demonstrates that the device is as safe and effective as the legally marketed devices.