(25 days)
The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.
The Medi-Pump is a portable AC powered home use suction pump. The device has been designed, tested and certified to UL 1431. The primary device components include a plastic enclosure, a piston style vacuum pump, a vacuum regulator and gauge, a 1000cc plastic collection jar with overflow valve, an in-line hydrophobic bacterial filter, and a 6' PVC patient tube.
The provided text primarily focuses on the 510(k) summary for the "Medi-Pump Model 1615 Aspirator," a medical device. This document is a regulatory submission to the FDA, and as such, it outlines the device's technical specifications, intended use, and substantial equivalence to a predicate device, rather than detailed study results or acceptance criteria in the manner one might find for a diagnostic or AI-driven device.
Therefore, many of the requested categories for acceptance criteria and study details cannot be fully answered from this specific document. The information available pertains to the device's performance characteristics as they relate to regulatory standards (UL 1431 and substantial equivalence to a predicate).
Here's an analysis based on the provided text, addressing what can be answered and indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the device's clinical performance, as would be expected for a diagnostic tool. Instead, it focuses on the device's adherence to regulatory and safety standards and its functional characteristics.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance |
|---|---|---|
| Safety Standard Compliance | Device must meet UL 1431 - Standard for Safety: Personal Hygiene and Health Care Appliances. | "The device has been designed, tested and certified to UL 1431." "Both models [1615 and predicate 1210] have been tested and certified to UL 1431." |
| Functional Equivalence | Must function as a portable AC powered home use suction pump for removing bodily fluids from airway/respiratory system. | The Medi-Pump 1615 aspirator is intended for this use. "In terms of construction, function, safety and effectiveness the Model 1615 is substantially equivalent to the model 1210 which is also a portable AC powered home use suction pump." |
| Vacuum Performance | (Implicit: Must provide adequate vacuum for aspiration, comparable to predicate). | "the device incorporates a slightly different style vacuum pump which provides a slightly higher vacuum" (This indicates it meets or exceeds the predicate's vacuum performance). |
| Overload Protection | Must have overload protection. | "is equipped with a single use (fuse) overload protector" |
| Power Plug Type | (Implicit: Type of power plug, likely for safety and compatibility). | "has a non-polarized power plug" |
| Design/Appearance | (Implicit: Modern, appealing appearance if design changes are made). | "the housing has been modified to provide a more updated, appealing appearance" |
| Component Specification | Must include specific components: plastic enclosure, piston style vacuum pump, vacuum regulator/gauge, collection jar, filter, patient tube. | The device description lists all these primary components. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. A 510(k) for this type of device typically relies on engineering testing and comparison to a predicate, not clinical trial data with test sets of patients as would be for a diagnostic tool or AI. The "testing" mentioned refers to engineering and safety standard compliance (e.g., UL 1431).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/available for this type of device and submission. "Ground truth" in the context of clinical expert consensus is not relevant to demonstrating substantial equivalence for a powered suction pump based on engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/available for this type of device and submission. Adjudication methods are typically used in clinical studies with human readers/interpreters, which is not the case here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/available. This is not an AI-assisted device, and no MRMC comparative effectiveness study is mentioned or relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/available. This is not an algorithmic or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied in diagnostic or AI studies is not directly applicable here. For this device, "ground truth" would be related to meeting established engineering and safety standards (e.g., UL 1431 requirements for vacuum, flow, electrical safety, etc.) and demonstrating functional equivalence to the predicate device. These are objective engineering measurements and comparisons, not clinical "ground truth" derived from patient data.
8. The sample size for the training set
This information is not available and not applicable, as this is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not available and not applicable, as this is not an AI or machine learning device.
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KO41199
JUN - 1 2004
"
Attachment 5: 510(k) Summary
Image /page/0/Picture/3 description: The image shows the logo for Rietschle Thomas, which is "A Thomas Industries Company". The logo is black and white and features a stylized graphic to the left of the company name. The company name is in a bold, sans-serif font.
Rietschie Thomas Sheboygan, Inc. 1419 Illinois Area of Bases Asemue
Phone: 920/451-4891
Fax: 920/457-4237 www.rtpumps.com
| Applicant: | Thomas Industries1419 Illinois AvenueSheboygan, WI 53082-0029Telephone: 920.451.0463Fax: 920.451.4357 |
|---|---|
| Contact Person: | Daniel Pfister, Regulatory Affairs SpecialistTelephone: 920.451.4252Fax: 920.451.4357 |
| Date Prepared: | April 22, 2004 |
| Trade Name: | Medi-Pump Model 1615 Aspirator |
| Product Classificationand Code: | Powered Suction Pump21 CFR §878.4780Classification: IIProduct Code: BTA - Pump, Portable, Aspiration |
| Predicate Device: | K944399 - Medi-Pump Model 1210 Aspirator |
| Device Description: | The Medi-Pump is a portable AC powered home use suction pump.The device has been designed, tested and certified to UL 1431. Theprimary device components include a plastic enclosure, a pistonstyle vacuum pump, a vacuum regulator and gauge, a 1000cc plasticcollection jar with overflow valve, an in-line hydrophobic bacterialfilter, and a 6' PVC patient tube. |
| Intended Use: | The Medi-Pump 1615 aspirator is intended to be used to removebodily fluids from a patient's airway or respiratory system. Theaspirator is intended for use in the home by professional homehealthcare providers and non-professional caregivers. |
| Summary ofTechnologicalCharacteristics: | The model 1615 differs from the predicate model 1210 in thefollowing characteristics; the housing has been modified to providea more updated, appealing appearance, the device incorporates aslightly different style vacuum pump which provides a slightlyhigher vacuum, is equipped with a single use (fuse) overloadprotector and has a non-polarized power plug. |
| Both models have been tested and certified to UL 1431 - Standardfor Safety: Personal Hygiene and Health Care Appliances. | |
| Conclusion: | In terms of construction, function, safety and effectiveness theModel 1615 is substantially equivalent to the model 1210 which isalso a portable AC powered home use suction pump. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
Mr. Daniel Pfister Regulatory Affairs Specialist Thomas Industries 1419 Illinois Avenue Sheboygan, Wisconsin 53082-0029
Re: K041199
Ko41177
Trade/Device Name: Medi-Pump Model 1615 Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 22, 2004 Received: May 7, 2004
Dear Mr. Pfister:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection > re(t) premium is substantially equivalent (for the indications relerenced above and nave decembers and for use stated in the encrosure) to regary management date of the Medical Device American Frank Free began commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in acceraapproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mercrore, maneer are act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivice and that your device complies with other requirements of the Act that I DX has Intact a and regulations administered by other Federal agencies. You must of any I catal statutes und regulations sincluding, but not limited to: registration and listing (21 Comply will an the 11cg (21 CFR Part 801); good manufacturing practice requirements as set CI IT ratt 6077, adomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byosins (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Daniel Pfister
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) 594-4659. 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 at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
ﮟ
510(k) Number (if known): K04 //99
Device Name: Medi-Pump Model 1615 Aspirator
Indications for Use:
The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K64/199
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.