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The Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by a single user.

The Synergy Gold (SG) Portable is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum levels within those modes. Massage mode consists of 5 suction levels, while expression mode has 12 suction levels. The SG Portable breast pump is capable of providing vacuum levels from 50-270 mmHz with cycling rate or 100 cycles per minute in massage mode and 26 cycles per minute in expression mode. The SG Portable breast pump is powered by a 5V DC adaptor or an internal rechargeable lithium-ion polymer battery.

The SG Portable breast pump is sold in two configurations (with and without breast shield and bottle sets). Model MM011450 includes the SG Portable breast pump, double collection kit (MM12302-C; breast shield set - medium 24 mm), power adapter, and two collection bottles. Model MM011460 includes the SG Portable breast pump and power adaptor: this model is to be used with separately purchased compatible breast shields and bottle sets.

The SG Portable breast pump and associated breast pump kits are intended for a single user.

The provided document is a 510(k) Premarket Notification from the FDA for a powered breast pump (Synergy Gold (SG) Portable). This type of document focuses on establishing substantial equivalence to a predicate device based on non-clinical testing, rather than extensive clinical studies or acceptance criteria for an AI/ML device.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/ML device, a study proving it meets those criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment methods for an AI/ML context.

The document primarily details:

• Device Name: Synergy Gold (SG) Portable (Models MM011450 and MM011460)
• Regulation Number: 21 CFR 884.5160
• Regulation Name: Powered Breast Pump
• Product Code: HGX
• Regulatory Class: II
• Predicate Device: K191208 Spectra Cashmere Breast Pump
• Intended Use: For lactating women to express and collect milk from their breast, intended for home use by a single user.
• Non-Clinical Testing Summarized: Electrical Safety (ANSI/AAMI ES60601-1:2005+A1:2012, IEC 60601-1-11:2015, IEC 62133:2012), Risk Analysis (ISO 14971:2007), Electromagnetic Compatibility (IEC 60601-1-2:2014), Biocompatibility (by reference to predicate), Software Validation ("Moderate" level of concern per FDA Guidance 2005), Bench Testing (vacuum, cycles, AC/battery power, various breast shield sizes, backflow protection), Battery and pump use-life testing.

The "acceptance criteria" discussed in this document refer to the device meeting its performance specifications through bench testing and compliance with electrical safety and EMC standards, a standard process for a physical medical device. It does not relate to the performance metrics of an AI/ML algorithm.

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