(119 days)
Not Found
No
The device is described as a "hand held passive tool" and an "accessory" that uses physical channels to control syringe plunger movement. There is no mention of software, algorithms, or any computational processing that would indicate the use of AI or ML. The performance studies describe empirical measurements and physical dimensions, not algorithmic performance.
No
The device is described as an accessory for syringes, designed to control the distance the syringe plunger can be drawn for accurate volumetric draws of liquids like vaccinations and medications. It facilitates precise drug delivery but does not directly treat or diagnose a disease or condition.
No
Explanation: The device is an accessory designed to control the distance a syringe plunger can be drawn to facilitate accurate volumetric draws of liquids; it does not diagnose any condition or disease.
No
The device description explicitly states the XTRACT Syringe Key is a "hand held passive tool" and describes its physical construction from polymers. It is a physical accessory, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control the distance a syringe plunger can be drawn to facilitate accurate and consistent volumetric draws of liquids from vials. These liquids are described as vaccinations, allergenic extracts, and medications. This is a device used for the preparation and administration of substances, not for testing biological samples to diagnose or monitor a medical condition.
- Device Description: The device is a passive tool that physically limits the movement of a syringe plunger. It does not interact with biological samples or perform any diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The focus is entirely on the mechanical control of liquid volume drawn into a syringe.
The device is an accessory for hypodermic syringes used for administering substances, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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,
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
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 Keys are available in sets that are designed and calibrated for the Terumo SurSaver Mixing Syringes (product code SS01A2313T) and/or the Greer . Optimix (GROM-23) SurSaver Mixing Syringes. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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."
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)
Performance Testing: 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 verify that all dimensions met drawing specifications and requirements as noted in Table No. 1. 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. 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, comparison testing was not possible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
First Article Testing: Average Deviation (g) for 0.0997g ideal was 0.00022, 0.1495g ideal was 0.00033, 0.2491g ideal was 0.00057, 0.4983g ideal was 0.00028, and 0.9965g ideal was 0.00017 with an overall average deviation of 0.00031g. Standard Deviation (g) for 0.0997g ideal was 0.00318, 0.1495g ideal was 0.00316, 0.2491g ideal was 0.00235, 0.4983g ideal was 0.00358, and 0.9965g ideal was 0.00438 with an overall standard deviation of 0.00291g.
Example values from user volume draw performance against visual dispensation from a bar graph are:
Visual Dispensation: Min 0.47mL, Nominal 0.49mL, Max 0.51mL.
Syringe Key: Min 0.46mL, Nominal 0.48mL, Max 0.49mL.
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.
Pavel Jordan & Associates, Inc.'s Count-A-Dose, K883311, SE Date: 09/15/1988
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
§ 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).
0
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).
1
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
2
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 |
5
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
0002 lindy unissimudus (ત્ર)
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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| F | |||
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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
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N นดทุ่วอร การเมริ รายชนิว รอย บุคคร ราคา นอมมาร เรนวินทร์ เรนอนุมมุร
Kogilza
co-
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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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.
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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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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.
10
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
11
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