(86 days)
Not Found
No
The device description focuses on mechanical controls (knobs for suction strength and rhythm) and does not mention any computational or adaptive features indicative of AI/ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used to express milk for feeding, which does not constitute treatment or prevention of a medical condition.
No
The provided text states that the device is "intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby." There is no mention of diagnosing any condition or disease.
No
The device description explicitly details physical components like control knobs, suction mechanisms, and bottle holders, indicating it is a hardware device with potentially embedded software, not a standalone software-only device.
Based on the provided information, 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 Lactaline Personal Powered Breast Pumps are designed to physically express and collect breast milk from a nursing woman. This is a mechanical process performed on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to "express and collect the mother's milk... for the purpose of feeding the collected milk to a baby." This clearly describes a physical action and its purpose, not a diagnostic test.
The device description and intended use align with a medical device used for a physical function, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
Product codes (comma separated list FDA assigned to the subject device)
85 HGX
Device Description
The Expresse and Premier powered breast pumps are intended to express the mother's milk of a nursing woman. The pumping can be performed on one breast or both breasts at the same time. A control knob adjusts the suction strength (vacuum) to one of 8 settings between
§ 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
DFC | 1997
Image /page/0/Picture/1 description: The image shows the word "Hollister" in a serif font next to a geometric symbol. The symbol is a stylized cross or asterisk shape, composed of several short, thick lines arranged symmetrically around a central void. The text and symbol are both black and appear to be slightly distressed or textured, giving them a vintage or worn look.
Hollister Incorporated 2009 Hollister Drive Libertyville, Illinois 60048-3781 1102
97350
Ameda Egnell Powered Breast Pumps Expresse and Premier
510(k) Summary
1. Sponsor's name, Address and Contact Person
- Contact Person Sponsor Joseph S. Tokarz AMEDA AG Manager, Regulatory Affairs Medizin-Technik Hollister Incorporated Bösch 106 2000 Hollister Drive CH-6331 Hünenberg Libertyville, IL 60048 Switzerland (847)680-2849 Ph: (847)918-3860 Fax:
Date Summary Prepared - September 12, 1997
2. Name of Device:
Expresse and Premier Powered Breast Pumps
3. Name of Predicate Device(s)
- · The Medela Lactina Breast Pump by Medela, K875300, April 6, 1988
- · The Medela Pump In Style Breast Pump (not known)
- · Egnell Elite Breast Pump by Ameda/Egnell, K950531, September 22, 1995
4. Description of Device
The Expresse and Premier powered breast pumps are intended to express the mother's milk of a nursing woman. The pumping can be performed on one breast or both breasts at the same time. A control knob adjusts the suction strength (vacuum) to one of 8 settings between