(227 days)
Not Found
No
The device description details a mechanical breast pump with user-controlled settings (knobs for speed and vacuum). There is no mention of AI, ML, or any adaptive or learning capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
A breast pump, while used for health and wellness, does not treat or diagnose a disease or condition, which is the definition of a therapeutic device.
No
The device is described as a breast pump for expressing milk, not for diagnosing any medical condition. Its function is to extract breast milk, which is a therapeutic/supportive action rather than a diagnostic one.
No
The device description clearly outlines a physical, electrically powered breast pump with a motor, diaphragm pump, control knobs, tubing, and breast cups. It is a hardware device with electrical and mechanical components, not solely software.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a breast pump. Its function is to physically extract breast milk from the breast. It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states "to express milk from the breast of lactating women." This is a mechanical function, not a diagnostic one.
Therefore, based on the provided information, this breast pump does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the electrically powered (diaphragm-type) suction device is to express milk from the breast.
The intended use of the electrically powered (diaphragmtype) suction device is to express milk from the breast of lactating women.
Product codes (comma separated list FDA assigned to the subject device)
85 HGX
Device Description
This portable electric breast pump model 1002 is powered by a variable speed DC motor that drives a diaphragm pump. The diaphragm pump creates the negative pressure reguired to extract breast milk. This pump has variable speed cycling rates, which is controlled by a knob located on the control panel. The breast pump is capable of providing multiple vacuum levels, which are user selectable by use of a knob located on the front panel. A maximum vacuum of 250-mm Hg. is applied to one or both breast through a disposable filter that is connected by way of flexible tubing to the breast cup(s).
It can be operated by use of either an AC/DC wall converter or a 12-Volt battery.
All materials used in the manufacturing of this device that has contact with food or human tissue meet requirement of the FDA and international regulations concerning food contact and/or biocompatability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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)
Not Found
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
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).
0
Name of Company: Limerick Inc. Premarket Notification - 510(k) Name of Devise: Portable Electric Breast Pump Model 1002
EXHIBIT #1 Page 1 Of 3
510(K) SUMMARY
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: KD21739
1. Submitter's Identification:
Limerick Inc. 903 North San Fernando Blvd., Suite 5 Burbank, California 91504
Date Summary Prepared: April 25, 20002
2. Name of the Device:
Portable Electric Breast Pump Model 1002
3. Predicate Devices Information:
Medela Pump In Style Breast Pump (510 (k) not known) Ameda Egnell Expresse and Premier Powered Breast pump K973501
4. Device Description:
This portable electric breast pump model 1002 is powered by a variable speed DC motor that drives a diaphragm pump. The diaphragm pump creates the negative pressure reguired to extract breast milk. This pump has variable speed cycling rates, which is controlled by a knob located on the control panel. The breast pump is capable of providing multiple vacuum levels, which are user selectable by use of a knob located on the front panel. A maximum vacuum of 250-mm Hg. is applied to one or both breast through a disposable filter that is connected by way of flexible tubing to the breast cup(s).
It can be operated by use of either an AC/DC wall converter or a 12-Volt battery.
All materials used in the manufacturing of this device that has contact with food or human tissue meet requirement of the FDA and international regulations concerning food contact and/or biocompatability.
1
Name of Company: Limerick Inc. Premarket Notification - 510(k) Name of Devise: Portable Electric Breast Pump Model 1002 EXHIBIT #1 Page 2 of 3
ર. Intended Use:
The intended use of the electrically powered (diaphragm-type) suction device is to express milk from the breast.
Comparison to Predicate Devices: 6.
Table of Comparison to Legally Marketed Device:
The following is a comparison chart outlining differences and similarities between Limerick Portable Electric Breast Pump Model 1002, Medela Pump In Style, the Expresse and Premier .:
| Proposed Device | Predicate Devices | |||
|---|---|---|---|---|
| Characteristics | Limerick Portable | |||
| Electric Breast | ||||
| Pump Model 1002 | Medela Pump In | |||
| Style-K unknown | Ameda/Egnell | |||
| Expresse | ||||
| K973501 | Ameda/Egnell | |||
| Premier | ||||
| K973501 | ||||
| Intended Use | As described in 21 | |||
| CFR 884.5160 | As described in 21 | |||
| CFR 884.5160 | As described in 21 | |||
| CFR 884.5160 | As described in 21 | |||
| CFR 884.5160 | ||||
| Suction Levels | 20-240 mm Hg. | 80-240 mm Hg. |