(15 days)
The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
The Ardo Suction Pumps master and senator are high performance suction pumps with maintenance-free glass piston/cylinder technology and a modern, functional design. They are the successor models of the egnell compact suction pump operating on the same basic principles. The mechanical over-flow safety device in the lid jar and the bacterial filter protect the pump against contamination. The suction pump is connected to the collection jars by means of collapse-resistant suction tubing. A longer piece of patient tubing is also connected to the jar. The latter transports the fluids from the patient to the jar. However, the tubing does not contact the patients directly. When the suction pump is switched to the ON position, the circuits direct electrical current from the external AC power supply to the pump/motor assembly. The pump operates to evacuate air from the collection jar. The resulting subatmospheric condition causes air to flow upward from the patient suction tubing and into the jars. Vacuum can be set by turning the adjustment knob. The difference between the master and senator is the suction capacity (master: 45 liter/minute, senator: 30 liter/minute). All other features are substantially equivalent.
The provided text does not contain detailed information regarding acceptance criteria for device performance or a specific study that proves the device meets those criteria in the context of clinical or diagnostic accuracy. Instead, it describes a medical device, the Ardo Suction Pumps (master and senator), and its regulatory submission (510(k)).
The document states that the device was tested against recognized international standards for medical suction equipment and general safety:
- ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction equipment
- ISO 10079-3: Medical Suction Equipment -- Part 1: Suction equipment powered from a vacuum or pressure source
- IEC 601-1: Medical Electrical Equipment -- Part 1: General requirements for safety
These standards typically define performance requirements (e.g., maximum vacuum pressure, flow rate, safety features) and testing methodologies for such devices. Therefore, the "acceptance criteria" are implied to be compliance with these standards, and the "study" is the testing performed against these standards.
Here's an attempt to answer your questions based only on the provided text, acknowledging that much of the requested information for AI/diagnostic devices is not applicable to this type of medical hardware submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 10079-1 | Device was tested against this standard |
| Compliance with ISO 10079-3 | Device was tested against this standard |
| Compliance with IEC 601-1 | Device was tested against this standard |
| Suction Capacity (Master model) | 45 liters/minute |
| Suction Capacity (Senator model) | 30 liters/minute |
| Mechanical overflow safety device | Present |
| Bacterial filter | Present |
| Maintenance-free glass piston/cylinder technology | Present |
Note: The document states the device "was tested" against these standards, implying compliance, as the FDA granted 510(k) clearance based on these tests.
2. Sample size used for the test set and the data provenance
- This information is not explicitly stated. For a hardware device like a suction pump, "sample size" typically refers to the number of units tested, which is not detailed.
- Data provenance: Not applicable in the context of clinical data. The tests were likely conducted in a laboratory setting by the manufacturer or a third-party testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. The "ground truth" for a mechanical device is its adherence to engineering specifications and safety requirements defined by the standards. No clinical experts were involved in establishing a diagnostic ground truth for this type of device.
4. Adjudication method for the test set
- Not applicable. The tests against the standards are objective measurements, not subjective evaluations requiring adjudication.
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
- Not applicable. This is a medical hardware device, not an AI/diagnostic imaging system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical hardware device, not an algorithm. The device functions independently in its suction capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is based on engineering specifications and safety standards (ISO 10079-1, ISO 10079-3, IEC 601-1). Compliance with these standards confirms the device's functional and safety performance.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for ARDO. The logo consists of the word "ARDO" in a simple, sans-serif font, with the letters evenly spaced. Above the word "ARDO" is a stylized graphic that resembles a leaf or a pair of wings. The graphic is shaded with a stippled effect, giving it a textured appearance.
JUN - 8 2001
Ardo Suction Pumps master, senator
510 (k) Summary
1. Submitted by:
Ardo medical AG Gewerbestrasse 19 6314 Unterägeri Switzerland Tel. +41-(0)41 754 70 70 Tel. +41-(0)41 754 70 71 ardo@info.ch - www.ardo.ch
2. Contact Person: Eva Krähenbühl, Marketing Manager
-
- Date Prepared: 18 April 2001
4. Product Classification:
- Device Name: Ardo Suction Pumps master, senator ●
- Common Name: Suction Pump
- Classification Name: Powered Suction Pump (per 21 CFR 878.4780) .
5. Predicate Devices:
- egnell compact suction pump by Ameda AG, K853917, November 25, 1985 .
- Dominant suction pump by Medela AG, K983552, January 7, 1999 .
6. Device Description:
The Ardo Suction Pumps master and senator are high performance suction pumps with maintenance-free glass piston/cylinder technology and a modern, functional design. They are the successor models of the egnell compact suction pump operating on the same basic principles.
The mechanical over-flow safety device in the lid jar and the bacterial filter protect the pump against contamination. The suction pump is connected to the collection jars by means of collapse-resistant suction tubing. A longer piece of patient tubing is also connected to the jar. The latter transports the fluids from the patient to the jar. However, the tubing does not contact the patients directly. When the suction pump is switched to the ON position, the circuits direct electrical current from the external AC power supply to the pump/motor assembly. The pump operates to evacuate air from the collection jar. The resulting subatmospheric condition causes air to flow upward from the patient suction tubing and into the jars. Vacuum can be set by turning the adjustment knob.
The difference between the master and senator is the suction capacity (master: 45 liter/minute, senator: 30 liter/minute). All other features are substantially equivalent.
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Image /page/1/Picture/0 description: The image shows the logo for ARDO. The logo consists of a stylized image of a plant or leaf above the word "ARDO" in a simple, sans-serif font. The plant image is composed of three sections, with the top section being the largest and the bottom two sections being smaller and more rounded.
Ardo Suction Pumps master, senator
7. Indications for Use:
The Ardo Suction Pumps master and senator are indicated for vacuum The Ardo Ouction Framoval of surgical fluids, tissue (including bone), extraction, aspliation and remover or strom wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
The indications for use for Ardo Suction Pumps master and senator are identical to the predicate device, Dominant, K983552.
8. Test:
The following standards were used in testing the suction pumps:
- ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction ● equipment
- ISO 10079-3: Medical Suction Equipment -- Part 1: Suction equipment . powered from a vacuum or pressure source
- IEC 601-1: Medical Electrical Equipment -- Part 1: General requirements for safety .
9. Conclusion:
It is concluded that the proposed Ardo Suction Pumps master and senator are safe and effective for their intended use and are substantially equivalent to the predicate devices.
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Public Health Service
JUN - 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ardo Medical Ag c/o Mr. Mark Job TÜV Product Service, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K011601
Trade/Device Name: Ardo Suction Pumps Master, Senator Regulation Number: 878.4780 Regulatory Class: II Product Code: BTA Dated: May 15, 2001 Received: May 24, 2001
Dear Mr. Job:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Mark Job
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
O. Mark N. Milburn
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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Page 1 of 1
510(k) Number (if known):_KO \ \ \ \ \ \
Device Name: Ardo Suction Pumps master, senator
Indications For Use:
The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration I he Ardo Daction Pumps nids, tissue (including bone), gases, bodily fluids or infectious and I cargical of bargion or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lion Mach n Melkus
(Division Sign-Off) (Division Sign of General, Restorative Divisiourological Devices
(Optional Format 3-10-98)
510(k) Number -
Prescription Use (Per 2) CFR & 801.109)
§ 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.