(119 days)
The XTRACT Solutions Syringe Keys are indicated as accessories for specified commercially available piston hypodermic syringes (for medical purposes) and designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and medications. The XTRACT Solutions Syringe Keys are designed and should be used only with the Terumo SurSaver Mixing Syringes (product code SS01A2313T) and/or the Greer Optimix (GROM-23) SurSaver Mixing Syringes,
The XTRACT Syringe Key is a hand held passive tool and an accessory designed to conveniently and ergonomically fit between the plunger thumb rest and the finger grip of piston hypodermic syringes. Designed to fit the Terumo SurSaver and Greer Optimix (GROM-23) Mixing Syringes, the XTRACT Syringe System facilitates the user in obtaining rapid, accurate and precise volumetric draws from vials containing vaccines, allergenic extracts and medications. The Syringe Key Set contains eight (8) individual Syringe Keys which are attached together by a stainless steel round-bead chain. A set contains keys for the following volumetric draws: 0.05 mL, 0.10 mL, 0.15 mL, 0.20 mL, 0.25 mL, 0.30 mL, 0.50 mL, 1.00 mL. Channels in both surfaces of the Key run along the width from edge to edge. The syringe plunger's thumb rest is inserted at one edge of the channel, the plunger is pulled from the syringe barrel as it is placed in the channel and the finger rest of the syringe barrel is located on the opposite channel edge. Materials used to fabricate the XTRACT Syringe Keys are polymers that have a long use in medical devices such as white delrin (polyoxymethylene) and polyethylene.
The XTRACT Syringe Key System is designed to assist users in obtaining accurate, consistent, and precise volumetric draws from vials using specific hypodermic syringes.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy and Precision of Volume Draws (Syringe Keys vs. Visual Dispensation) | Syringe Keys should facilitate more accurate, precise, and reproducible volume draws compared to the standard visual method. | Performance data in Tables No. 2, 3, 4, 5, and 6 (not fully provided in text, but summarized) demonstrates that "the Syringe Keys facilitate the user in obtaining more accurate, precise and reproducible volume draws as compared to the standard method or visualization procedure." Specific data for "Syringe Key Dispensation" (Figure 8) and "Visual Dispensation" (Figure 5) for a 0.50 mL draw suggest: - Visual Dispensation (0.5 mL aim): Min ~0.47 mL, Nominal ~0.49 mL, Max ~0.51 mL. - Syringe Key Dispensation (0.5 mL aim): Min ~0.44 mL, Nominal (not labeled, but falls within tighter range), Max ~0.49 mL. This visually indicates a tighter range and potentially improved accuracy for the Syringe Key. |
| Physical Dimensions / Manufacturing Accuracy (First Article Inspection) | All dimensions must meet drawing specifications and requirements. | Confirmed by "First Article Inspection... to verify that all dimensions met drawing specifications and requirements as noted in Table No. 1." Table No. 1 shows measured channel distances for various mL volumes (e.g., for 0.1mL, Nominal: 0.7481 inch, Samples 1-3: 0.7475, 0.7475, 0.7470 inch). These values are very close to nominal, indicating adherence to specifications. |
| Material Composition | Use of polymers with a long history in medical devices. | Materials used are "white delrin (polyoxymethylene) and polyethylene," which "have a long use in medical devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For the volume withdrawal accuracy test: "Weight measurement analyses were conducted on each of the five (5) different Syringe Keys at a minimum of 3 times." This refers to 5 specific keys (likely corresponding to 0.1mL, 0.15mL, 0.25mL, 0.5mL, and 1.0mL as per Table No. 1 and the mass data), each tested at least 3 repetitions.
- One table (on what appears to be page 6 of the original document) shows performance data for "Syringe Key" A, B, C, and D, with 3 repetitions each for 5 different key volumes (0.1mL, 0.15mL, 0.25mL, 0.5mL, 1.0mL). This would be 4 Syringe Keys * 3 repetitions * 5 volumes = 60 measurements for mass (which correlates to volume).
- Data Provenance: The studies were conducted by XTRACT Solutions, LLC. The context implies these were internal performance tests for FDA submission. Details on country of origin are not explicitly stated, but the submission is to the US FDA, and the company address is in Portland, OR, USA, suggesting the testing likely occurred in the USA. The testing appears to be prospective, specifically for this device's submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- There is no mention of experts being used to establish a ground truth for the performance testing. The "ground truth" for the volumetric accuracy was established by precise weighing of dispensed water, which is an objective measurement based on physical properties.
4. Adjudication Method for the Test Set:
- Not applicable, as the performance testing involves objective measurements (weighing dispensed liquid and physical dimensions) rather than subjective expert evaluation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study compared the device's performance to "standard method or visualization procedure" (human activity without the device) and "Syringe Key dispensation" (human activity with the device), but it was not structured as a typical MRMC study designed to measure human reader improvement with AI assistance.
- Effect Size: While not an MRMC study, the performance data (summarized as Tables No. 2-6, and visually represented in Figures 5 and 8 for 0.5mL) indicates that the Syringe Keys lead to "more accurate, precise and reproducible volume draws." The visual data for 0.5mL (Figures 5 and 8) shows a narrower range for the Syringe Key Dispensation (0.44-0.49 mL) compared to Visual Dispensation (0.47-0.51 mL), suggesting an improvement in precision and potentially accuracy. However, specific effect sizes (e.g., percentage improvement) are not quantified in the provided text.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. The device, the XTRACT Syringe Key, is a passive mechanical accessory. Its function is inherently "human-in-the-loop" as it assists a user in performing a task. There is no algorithm or standalone performance without human interaction.
7. Type of Ground Truth Used:
- The ground truth used for the performance testing of the Syringe Keys was based on objective physical measurement:
- Volumetric Accuracy: Determined by weighing dispensed water ("liquid was drawn from the vials and dispensed into tarred weighing dishes and subsequently weighed"). The ideal weight for various volumes was pre-established (e.g., "Ideal (g)" values in the table on page 6).
- Physical Dimensions: Verified against "drawing specifications and requirements" through a "First Article Inspection," which involves direct measurement of the manufactured keys.
8. Sample Size for the Training Set:
- Not applicable. This device is a mechanical accessory, not an AI/ML algorithm that requires a training set. The "design" process involved "establishing an empirical (not just mathematic) relationship of plunger travel to dispensed volume (weight)" and then using this data to "establish the ideal physical size of the syringe keys." This would be considered engineering design and calibration, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set in the context of an AI/ML algorithm. The "ground truth" for the design of the keys was established by empirical measurement of the syringe system's behavior (plunger travel vs. dispensed volume by weight).
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Kori 200
AUG 2 1 2009
Image /page/0/Picture/3 description: The image shows the logo for Xtract Solutions. The logo is black and white and features the word "Xtract" in large, bold letters. A syringe is placed vertically in the middle of the word, replacing the letter "T". Below the word "Xtract" is the word "Solutions" in smaller letters.
4.0 510(k) Summary:
In accordance with 21 CFR Section 807.92, XTRACT Solutions, LLC. Is submitting the following 510(k) Summary:
4.1 Submitter Information -
XTRACT Solutions, LLC. 9495 SW Locust, Suite E Portland, OR 97233, USA FDA Registration No .: Pending Owner / Operator No .: EIN 931264310
4.2 Preparer of Submission and Contact for Information -
Lowrey RA/QA Solutions, Inc. Keith Lowrey, Managing Director 611 South Schoolhouse Creek Rd. Grants Pass. OR 97526 Phone: 541-476-1628
4.3 Name of Device -
4.3.1 Trade / Proprietary Name:
XTRACT Syringe Key System.
4.3.2 Common / Usual Name:
Hypodermic Syringe Accessory Spacer or Holder
4.3.3 Classification Name:
Accessory Device to Piston Hypodermic Syringe
4.4.4 Regulation Number:
21 CFR 880.5860
4.4.5 Product Code:
The product code for the Syringe Keys is FMF.
4.4.6 Class:
Class II (performance standards).
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2 x 9
4.4 Substantial Equivalence -
This submission establishes the substantial equivalence of the XTRACT Solutions, LLC., Syringe Keys as an accessory to piston hypodermic syringes such as the following predicate device:
Pavel Jordan & Associates, Inc.'s Count-A-Dose, K883311, SE Date: 09/15/1988. 4.4.1
4.5 Description of the Device -
- 4.5.1 The XTRACT Syringe Key is a hand held passive tool and an accessory designed to conveniently and ergonomically fit between the plunger thumb rest and the finger grip of piston hypodermic syringes.
Image /page/1/Picture/7 description: The image shows a white, plastic key. The key has a rounded head with a hole in it, and a rectangular body with two notches on either side. The key is lying on a dark surface. The image is a close-up of the key, and the background is blurred.
Figure 1 0.05 mL Syringe Key
Image /page/1/Picture/9 description: In the image, a pair of tweezers is holding a small, white object. The object appears to be a small piece of material, possibly a crystal or a small fragment of something. The tweezers are silver in color and are positioned to hold the object securely. The background is dark and out of focus, which helps to highlight the object and the tweezers.
Syringe Key fits between plunger Figure 2 thumb rest and finger grip
- 4.5.2 Designed to fit the Terumo SurSaver and Greer Optimix (GROM-23) Mixing Syringes, the XTRACT Syringe System facilitates the user in obtaining rapid, accurate and precise volumetric draws from vials containing vaccines, allergenic extracts and medications.
Image /page/1/Picture/12 description: The image shows a gray object with an arrow pointing from the top left to the right, then down to the bottom left. The object has a rectangular shape on the left side and a rounded shape on the right side. There is a small hole on the bottom left of the object.
Figure 3 Syringe barrel finger grips Plunger thumb rest
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4.6 Indications for Use -
The XTRACT Solutions Syringe Keys are indicated as accessories for specified commercially available piston hypodermic syringes (for medical purposes) and designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and medications. The XTRACT Solutions Syringe Keys are designed and should be used only with the Terumo SurSaver Mixing Syringes (product code SS01A2313T) and/or the Greer Optimix (GROM-23) SurSaver Mixing Syringes,
4.7 Specifications -
- The Syringe Keys are available in sets that are designed and calibrated for the 4.7.1 Terumo SurSaver Mixing Syringes (product code SS01A2313T) and/or the Greer . Optimix (GROM-23) SurSaver Mixing Syringes.
Image /page/2/Picture/5 description: The image shows a close-up of a mechanical part, possibly a component from a machine or engine. The part is metallic and has a complex shape with a series of ridges or teeth along one edge. There are also some circular features and a small hole on the top surface of the part.
Figure 4 XTRACT Syringe Key Se
- 4.7.2 The Syringe Key Set contains eight (8) individual Syringe Keys which are attached together by a stainless steel round-bead chain. A set contains keys for the following volumetric draws:
| Key Volume: |
|---|
| 0.05 mL |
| 0.10 mL |
| 0.15 mL |
| 0.20 mL |
| 0.25 mL |
| 0.30 mL |
| 0.50 mL |
| 1.00 mL |
0011
{3}------------------------------------------------
- 4.7.3 Channels in both surfaces of the Key run along the width from edge to edge. The syringe plunger's thumb rest is inserted at one edge of the channel, the plunger is pulled from the syringe barrel as it is placed in the channel and the finger rest of the syringe barrel is located on the opposite channel edge.
Image /page/3/Picture/3 description: The image shows a close-up of a concrete structure, possibly a wall or a building corner, with a rough, textured surface. The structure is partially obscured by what appears to be foliage or vegetation in the background, creating a contrast between the solid, man-made material and the natural elements. Two white lines are drawn on the concrete structure, forming a V shape. The lighting in the image is somewhat uneven, with some areas appearing brighter than others, which adds to the texture and depth of the scene.
Figure 5 Channel across the width of the Syringe Key.
- 4.7.4 The XTRACT Solutions Syringe Keys will be sold by prescription only and labeling with bear the statement, "Caution: Federal Law restricts this device to sale by or on the order of a physician."
4.8 Technological Characteristics in Comparison to the Predicates -
4.8.1 Predicate Device -
The XTRACT Solutions Syringe Key System is substantially equivalent to the Pavel Jordan & Associates, Inc.'s Count-A-Dose, K883311, SE Date: 09/15/1988.
Count-a-Dose Insulin Holder
Description - The simple way to fill insulin syringes safely and accurately.
Manufacturer: MEDICOOL INC
Image /page/3/Picture/12 description: The image shows a product called "Count-a-dose". The product is designed to be simple to fill, reliable, standard, and accessible. The product is designed to count pills and tablets. The image shows a row of pills in the product.
0012 (a)
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows handwritten text. The text at the top appears to be a series of numbers, possibly '10912006'. Below this, there is another line of text that reads '5 of 9'. The handwriting is somewhat stylized, with distinct shapes for the numbers and letters.
4.8.2 Materials -
Materials used to fabricate the XTRACT Syringe Keys are polymers that have a long use in medical devices such as white delrin (polyoxymethylene) and polyethylene. The Count-A-Dose 510(k) documentation provides no information about materials used to make the device.
4.8.3 Performance Comparison-
As an accessory for the hypodermic syringe, the Syringe Keys and the Count-A-Dose are designed to control the distance that the syringe plunger can be pulled through the syringe barrel by functioning as a "spacer" fitting on the plunger between the thumb rest and the barrel's finger rest/flange. The devices assist the user in withdrawing precise and accurate liquid volume withdraws from a vial. The devices do not facilitate or assist the user with injecting the contents of the hypodermic syringe.
Image /page/4/Figure/6 description: The image contains two figures side by side. Both figures show a hand holding a small, rectangular object, possibly a piece of paper or card. The hand appears to be manipulating or examining the object, with a tool or pointer directed towards it in both figures.
Figure 6 Plunger thumb rest in channel. Figure 7 Key Grip is used to handle the Syringe Key.
4.9 Performance Testing -
- 4.9.1 The Syringe Keys were designed by first establishing an empirical (not just mathematic) relationship of plunger travel to dispensed volume (weight). This data was then used to establish the ideal physical size of the syringe keys (the "Syringe Key Design" worksheet). This process was used with each of the eight (8) volume sizes of each key from the Syringe Key Sets.
- Upon receipt of the machined prototypes, a First Article Inspection was performed to 4.9.2 verify that all dimensions met drawing specifications and requirements as noted in Table No. 1.
| Table No. 1, First Article Report | ||||||
|---|---|---|---|---|---|---|
| Draw Volume (mL) vs. Syringe Key Channel Distance (Inches) | ||||||
| Sample | mL | 0.1mL | 0.15mL | 0.25mL | 0.5mL | 1.0mL |
| Nominal | inch | 0.7481 | 0.8622 | 1.0905 | 1.6612 | 2.8026 |
| 1 | 0.7475 | 0.8630 | 1.0905 | 1.6580 | 2.7970 | |
| 2 | 0.7475 | 0.8615 | 1.089 | 1.6605 | 2.8020 | |
| 3 | 0.7470 | 0.8610 | 1.090 | 1.6610 | 2.8016 |
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K091200
689
The channel length measurements of the actual syringe keys and the "draw volumes" were evaluated and compared. Using the Syringe Keys, piston hypodermic syringes with needles were introduced into the septums of vials containing H2O.
The liquid was drawn from the vials and dispensed into tarred weighing dishes and subsequently weighed. Weight measurement analyses were conducted on each of the five (5) different Syringe Keys at a minimum of 3 times.
- 4.9.3 Performance data demonstrates that the Syringe Keys facilitate the user in obtaining more accurate, precise and reproducible volume draws as compared to the standard method or visualization procedure. See Tables No. 2, 3, 4, 5 and 6.
- Because the Count-A-Dose device is no longer being manufactured and not available, 4.9.4 comparison testing was not possible.
0013
{6}------------------------------------------------
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ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺮﺍﺟﻊ
Strategic
First Artricle Testing conducted on first articles received from Maxwell Mold (#500) on 06/06/08
| Mass (Grams) | Deviation Validation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Syringe | Key | 0.1mL | 0.15mL | 0.25mL | 0.5mL | 1.0mL | Sum | Normalized | 0.1mL | 0.15mL | 0.25mL | 0.5mL | 1.0 mL | Average |
| Ideal (g) | 0.0997 | 0.1495 | 0.2491 | 0.4983 | 0.9965 | 1.9931 | 39.862 | 0 | 0 | 0 | 0 | 0 | 0 | |
| A | 1 | 0.103 | 0.151 | 0.249 | 0.502 | 0.993 | 1.998 | 39.96 | 0.0033 | 0.0015 | -1E-04 | 0.0037 | -0.0035 | |
| 2 | 0.1 | 0.15 | 0.25 | 0.501 | 1 | 2.001 | 40.02 | 0.0003 | 0.0005 | 0.0009 | 0.0027 | 0.0035 | 0.00165 | |
| 3 | 0.103 | 0.149 | 0.251 | 0.502 | 1 | 2.005 | 40.1 | 0.0033 | -0.0005 | 0.0019 | 0.0037 | 0.0035 | ||
| B | 1 | 0.101 | 0.154 | 0.252 | 0.497 | 0.992 | 1.996 | 39.92 | 0.0013 | 0.0045 | 0.0029 | -0.0013 | -0.0045 | |
| 2 | 0.101 | 0.151 | 0.251 | 0.502 | 1 | 2.005 | 40.1 | 0.0013 | 0.0015 | 0.0019 | 0.0037 | 0.0035 | ||
| 3 | 0.104 | 0.153 | 0.253 | 0.501 | 1 | 2.011 | 40.22 | 0.0043 | 0.0035 | 0.0039 | 0.0027 | 0.0035 | ||
| C | 1 | 0.099 | 0.151 | 0.252 | 0.496 | 0.995 | 1.993 | 39.86 | -0.0007 | 0.0015 | 0.0029 | -0.0023 | -0.0015 | |
| 2 | 0.1 | 0.152 | 0.25 | 0.5 | 1.002 | 2.004 | 40.08 | 0.0003 | 0.0025 | 0.0009 | 0.0017 | 0.0055 | 0.00145 | |
| 3 | 0.102 | 0.151 | 0.249 | 0.5 | 1.002 | 2.004 | 40.08 | 0.0023 | 0.0015 | -1E-04 | 0.0017 | 0.0055 | ||
| D | 1 | 0.095 | 0.144 | 0.246 | 0.491 | 0.99 | 1.966 | 39.32 | -0.0047 | -0.0055 | -0.0031 | -0.0073 | -0.0065 | |
| 2 | 0.094 | 0.144 | 0.247 | 0.497 | 0.993 | 1.975 | 39.5 | -0.0057 | -0.0055 | -0.0021 | -0.0013 | -0.0035 | -0.00402 | |
| 3 | 0.097 | 0.148 | 0.246 | 0.494 | 0.993 | 1.978 | 39.56 | -0.0027 | -0.0015 | -0.0031 | -0.0043 | -0.0035 | ||
| Average (g) | 0.09992 | 0.14983 | 0.24967 | 0.49858 | 0.99667 | Average Deviation (g) | 0.00022 | 0.00033 | 0.00057 | 0.00028 | 0.00017 | 0.00031 | ||
| Std. Deviation | 0.00318 | 0.00316 | 0.00235 | 0.00358 | 0.00438 | Std. Deviation (g) | 0.00318 | 0.00316 | 0.00235 | 0.00358 | 0.00438 | 0.00291 |
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{7}------------------------------------------------
ខេត្តព្រះវាជា របស់ខាត់ ព្រះមហាក្សា វិសេស នៅក្នុង ស្រុកក្រុង របស់ព្រះ បានការ
ខេត្តពេរមុខ ភូមិ ពេលទៅ។ ពេលទាំង វាមទៅវិជ្ជា ស្រាក់ព្រែក ប្រាសាទ នាទទួល ទទាក់វី – ជានិបា ពលទីរាជប
| Lynn Miller | Ann McAdams | Brooke Jeppson | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Syringe A | Syringe B | Syringe A | Syringe B | Syringe A | Syringe B | ||||||||||||
| 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | ||||||
| 0.05 mL | 0.06 | 0.06 | 0.07 | 0.06 | 0.06 | 0.06 | 0.06 | 0.06 | 0.06 | 0.06 | 0.07 | 0.06 | 0.06 | 0.06 | 0.06 | 0.05 | 0.06 |
| 0.15 mL | 0.16 | 0.16 | 0.17 | 0.17 | 0.16 | 0.15 | 0.16 | 0.16 | 0.16 | 0.16 | 0.17 | 0.16 | 0.16 | 0.16 | 0.16 | 0.15 | 0.16 |
| 0.20 mL | 0.21 | 0.21 | 0.21 | 0.2 | 0.21 | 0.21 | 0.21 | 0.21 | 0.21 | 0.21 | 0.2 | 0.21 | 0.2 | 0.21 | 0.21 | 0.21 | 0.2 |
| 0.30 mL | 0.31 | 0.3 | 0.31 | 0.31 | 0.31 | 0.3 | 0.3 | 0.3 | 0.3 | 0.31 | 0.31 | 0.31 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
| 0.50 mL | 0.51 | 0.5 | 0.5 | 0.5 | 0.51 | 0.5 | 0.48 | 0.5 | 0.49 | 0.51 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.4 |
| 1.00 mL | 0.99 | 0.99 | 0.99 | 0.99 | 1 | 0.99 | 0.97 | 0.98 | 0.98 | 0.99 | 0.99 | 0.99 | 0.99 | 0.99 | 0.99 | 0.98 | 0.9 |
| grams | grams | grams | grams | grams | grams |
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A ,noiszimdus (x)017 гг. гуэд эрлігу2 ТЭАЯТХ ,Элт ,гпоійног тэл
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Image /page/8/Figure/2 description: The image is a bar graph that shows the volume in mL for visual dispensation and syringe key. The x-axis shows the volume in mL, ranging from 0.46 to 0.52. For visual dispensation, the minimum volume is around 0.47 mL, the nominal volume is around 0.49 mL, and the maximum volume is around 0.51 mL. For the syringe key, the minimum volume is around 0.46 mL, the nominal volume is around 0.48 mL, and the maximum volume is around 0.49 mL.
ədə bir növü. İstinadlar Şəhər Qaraq məşğul oluna vəsanların qalınmış və qalınmış və qalınmış və qalınmış və qalınmış və qalınmış və qalınmış və qalının qalınmış və qalını
dləm başburğu 10 noitsanəqsid İsusiV ,9 .ol1 əldə
Image /page/8/Figure/5 description: The image is a bar graph titled "Visual Dispensation". The graph shows the values for Min, Nominal, and Max. The values for Min, Nominal, and Max are approximately 0.5, 0.48, and 0.46 respectively.
itesueqsiQ yeA ອຖູກການປູລ 17 .0M ອາປ
Image /page/8/Figure/8 description: The image is a bar graph titled "Syringe Key Dispensation". The graph shows the minimum value is 0.44 and the maximum value is 0.49. The graph also includes a nominal value, but the exact value is not labeled.
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ນາວອຣ ໂຍຍມາກຣ (ນ)ປ່ຽ ເມຍາຣ໌ເຣ ໂອງ ອົນເມຣິ ປະຈຸບັນ ອົນເມຣິນາ ເປັນນາ
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Image /page/9/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's emblem, which features a stylized caduceus-like symbol with three abstract shapes resembling birds in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
XTRACT Solutions, LLC C/O Mr. Keith Lowrey Solutions MDI. Incorporated 611 South Schoolhouse Creek Road Grants Pass, Oregon 97526
AUG 21 2009
Re: K091200
Trade/Device Name: XTRACT Syringe Keys Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 28, 2009 Received: August 12, 2009
Dear Mr. Lowrey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lowrey
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anthony D., Newton be
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): To be determined by FDA
Device Name:
XTRACT Syringe Keys
Indications for Use:
The XTRACT Solutions Syringe Keys are indicated as accessories for specified commercially available piston hypodermic syringes (for medical purposes) and designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and medications. The XTRACT Solutions Syringe Keys are designed and should be used only with the Terumo SurSaver Mixing Syringes (product code SS01A2313T) and/or the Greer Optimix (GROM-23) SurSaver Mixing Syringes
Prescription Use X (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
KOS$200
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
0007
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).