(296 days)
the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Proprietary Name : SE-30 TENS Common or Usual Name : Transcutaneous Electrical Nerve Stimulator Classification Name : Stimulator, Nerve, Transcutaneous (Pain Relief)
The SEIN SE-30 TENS device is equivalent to the Graham-Field, Inc. Micro TENS Plus transcutaneous electrical nerve stimulator.
Each product is used for the symptomatic relief of and management of long term intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
One output channel, Asymmetric bi-phasic & phasic rectangular shape with zero net direct current, Pulse Width 105-450 us programmed insert protected circuit, Pulse Rate 1-200 pulse/sec programmed, Power Source two alkaline AAA batteries 1.5 volt, Maximum Voltage Load 200 ohm 26 V, 500 ohm 40 V, 1 Kohm 52 V, open 90 V, Maximum Output charge/pulse (500 ohm load for safety) 58.5 uc/pulse, Maximum Output average current (500 ohm load for safety) 3.375 mA, Size 70(W) x 79(H) x 17(D) mm, Weight 80 grams, Recharge Battery Option N, Battery Check N, Water Use Option N, Discriminate Polality Automatically Change, Gel Pad Adhesive Type, Treatment 15 min. (no daily limit), MODES AVAILABLE Mode 1: [Modulation] 1. Pulse Rate : 1-100 pps 2. Pulse Width: 220-450 usec, Mode 2... [Burst] 1. Pulse Rate: 16 pulse/burst. 4b/sec 16 pulse/burst. 7b/sec 63-125 pps 2. Pulse Width : 105-450 usec, Mode 3... [Modulation] 1. Pulse Rate : 1-5 pps 2. Pulse Width : 220 usec, Mode 4... [Burst] 1. Pulse Rate: 220 pulse/burst, 1b/sec 90 pulse/burst. 1b/sec 2. Pulse Width: 220-450 usec
Here's an analysis of the provided text regarding the SEIN SE-30 TENS device, framed by the requested acceptance criteria and study information.
It's important to note that the provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. For such devices, "acceptance criteria" and "study" typically refer to demonstrating substantial equivalence to a predicate device, as well as adherence to recognized performance standards. This is different from the type of clinical performance study often associated with AI/software devices. The acceptance criteria here are about demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Acceptance Criteria and Study for SEIN SE-30 TENS Device
The SEIN SE-30 TENS device demonstrated substantial equivalence to a predicate device (Graham-Field, Inc. Micro TENS Plus) and compliance with the ANSI/AAMI NS4-1985 standard. The "acceptance criteria" are implied by these comparisons and the requirements of the 510(k) process for demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For a TENS device seeking 510(k) clearance, the "acceptance criteria" are generally met by demonstrating that the device is as safe and effective as a legally marketed predicate device and complies with relevant performance standards. The reported device performance is primarily a comparison of technical specifications.
| Acceptance Criteria (Implied) | SEIN SE-30 TENS Reported Performance | Satisfies? |
|---|---|---|
| Substantial Equivalence: | ||
| - Equivalent intended use | Symptomatic relief and management of chronic pain, post-surgical/post-traumatic pain. (Identical to predicate) | Yes |
| - Similar technological characteristics (where differences don't raise new questions of safety/effectiveness) | See "Comparison of General Specifications" below; differences evaluated by FDA. | Yes |
| Compliance with Recognized Standards: | ||
| - ANSI/AAMI NS4-1985 (Electromyographs and Evoked Potential Instruments) | Device was tested and found to meet the requirements of ANSI/AAMI NS4-1985. | Yes |
Comparison of General Specifications between SEIN SE-30 TENS and GRAHAM-FIELD Micro TENS Plus (Predicate Device)
| ITEM | SEIN SE-30 TENS | GRAHAM-FIELD Micro TENS Plus |
|---|---|---|
| Output Channels | One output channel | Two with individual controls |
| Pulse Shape | Asymmetric bi-phasic & phasic rectangular shape with zero net direct current | Asymmetric bi-phasic & phasic rectangular shape with zero net direct current |
| Pulse Width | 105-450 us programmed | 50-200 us variable |
| Pulse Rate | 1-200 pulse/sec programmed | 1-200 pulse/sec variable |
| Power Source | 2 alkaline AAA batteries 1.5 volt | 9 volt alkaline or NiCd bat. (rechargeable option) |
| Max. Voltage (200 ohm) | 26 V | 17 V |
| Max. Voltage (500 ohm) | 40 V | 32 V |
| Max. Voltage (1 Kohm) | 52 V | 45 V |
| Max. Voltage (open) | 90 V | 90 V |
| Max. Output charge/pulse (500 ohm load) | 58.5 uc/pulse | 14.3 uc/pulse |
| Max. Output average current (500 ohm load) | 3.375 mA | 2.3 mA |
| Size | 70(W) x 79(H) x 17(D) mm | 90(W) x 59(H) x 25(D) mm |
| Weight | 80 grams | 142 grams |
| Recharge Battery Option | N | Y |
| Battery Check | N | Y |
| Water Use Option | N | Y |
| Discriminate Polarity | Automatically Change | Required |
| Gel Pad | Adhesive Type | Adhesive Type |
| Modes Available | Mode 1: Modulation (1-100 pps, 220-450 usec) | |
| Mode 2: Burst (16 p/burst, 4/7 b/sec, 63-125 pps, 105-450 usec) | ||
| Mode 3: Modulation (1-5 pps, 220 usec) | ||
| Mode 4: Burst (220/90 p/burst, 1 b/sec, 220-450 usec) | Constant Mode (1-200 pps, 50-200 usec) | |
| Burst Mode (10 p/burst, 2 b/sec, 50-200 usec) | ||
| Modulation Mode (1-200 pps, 50-200 usec) |
2. Sample Size Used for the Test Set and Data Provenance
For TENS devices seeking 510(k) clearance, there isn't typically a "test set" in the sense of a dataset for an AI algorithm. Instead, the "test" involved comparing the new device against a predicate device's specifications and performance against a recognized standard (ANSI/AAMI NS4-1985).
- Sample Size for Test Set: Not applicable in the context of a dataset for an AI algorithm. The "test" involved a single physical SEIN SE-30 TENS device being evaluated against specifications and standards.
- Data Provenance: The data is primarily derived from engineering specifications, design documents, and testing results of the SEIN SE-30 TENS device, alongside the known specifications of the predicate device. The testing was conducted by SEIN Electronics Co., Ltd. in Korea. It's a "prospective" evaluation in the sense that the device was specifically tested to meet the standard and demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of establishing ground truth for image/data interpretation. This summary does not mention any expert review of clinical cases.
- Qualifications of Experts: Not applicable. The "ground truth" for this regulatory submission is the established performance characteristics of the predicate device and the requirements of the ANSI/AAMI NS4-1985 standard.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no "test set" in the context of clinical data requiring expert adjudication. The comparison was primarily based on objective technical specifications and standard compliance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This type of study is not typically required or performed for TENS device 510(k) submissions, which focus on electromechanical similarity and performance standard compliance rather than diagnostic accuracy or human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The SE-30 TENS is a physical medical device, not an AI algorithm. Its performance is inherent in its design and operation, not subject to standalone algorithmic testing.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is:
- The established technical specifications and therapeutic claims of the legally marketed predicate device (Graham-Field, Inc. Micro TENS Plus).
- The requirements of the recognized industry standard ANSI/AAMI NS4-1985.
- The intended use for Transcutaneous Electrical Nerve Stimulators (pain relief).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The SEIN SE-30 TENS is a physical TENS device and does not involve machine learning or a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
In summary, the K991397 submission for the SEIN SE-30 TENS device demonstrated its "acceptance criteria" were met by proving substantial equivalence to a predicate device through a comparison of technical specifications and by showing compliance with a relevant performance standard (ANSI/AAMI NS4-1985). The framework of AI/software device evaluation (test sets, ground truth by experts, MRMC studies) does not directly apply to this traditional medical device submission.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).