(73 days)
The product family of Xtract Solutions Syringe Keys are indicated as accessories provided for specified commercially available piston hypodermic syringes (for medical purposes) which are 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 other medications. The Syringe Keys (available for 1mL and/or 3 mL hypodermic syringes) are designed as an accessory only for the following syringes:
1 mL syringes:
. 1 mL Terumo SurSaver Mixing Syringes (SS01A2313T) and/or
. 1 mL Greer Optimix (GROM-23) SurSaver Mixing Syringe.
1.1.2 3 mL syringes:
. 3 mL VanishPoint (RTI10311) Syringes, 23g x 1"
. 3 mL BD SafetyGlide (BD305905) Syringes, 23g x 1" .
. 3 mL BD Integra (BD305271) Syringes 23g x 1"
. 3 mL BD Precision Glide (BD309578) Syringes 20g x 1" .
1.2 The device assists the user in withdrawing precise and accurate liquid volume withdraws from a vial. The Syringe Keys do not facilitate or assist the user with injecting the contents of the hypodermic syringe.
1.3 The Syringe Keys can be used by medical personnel as well as individuals who are not medical professionals; but, have been instructed in their use.
1.4 Syringe Keys will be available for specified piston hypodermic syringe models manufactured by designated syringe manufacturers.
The Xtract Solutions 3 mL 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. The 3 mL Syringe Key facilitates the user in obtaining rapid and accurate volumetric with-drawls from vials containing vaccines and other medications. The Syringe Key has been re-designed for ergonomic improvement for the user and to fit four (4) additional piston hypodermic syringes. The 3 mL Syringe Key is 5 inches long and is curved to fit comfortably in the user's hand. At the top of the Key on the underside are three features: Teeth, Groove, and Notch. The plunger is pulled slightly from the syringe barrel and the plunger thumb rest is then nested into a precise slot located at the proximal end of the Syringe Key. After seating the thumb rest in the Syringe Key, the syringe's barrel is moved backward against the proximal flat face of the Syringe Key.
The provided 510(k) summary for the "Xtract 3mL Syringe Keys" mainly focuses on establishing substantial equivalence to a predicate device and describing the device itself. It includes limited information regarding detailed acceptance criteria or a comprehensive study report. However, based on the available text, we can extract some information related to performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds. However, the performance testing section details the process and presents example data for one of the syringe key types. From this, we can infer the implied performance objective related to volume accuracy and precision.
| Acceptance Criteria (Implied) | Reported Device Performance (Example Data for BD 3 mL Integra Syringes, 0.5 mL Draw) |
|---|---|
| Accuracy: Individual draws should be close to the target volume (e.g., 0.5 mL). | Syringe #1 Average: 0.500 mL |
| Syringe #2 Average: 0.502 mL | |
| Precision: Low variability (standard deviation) between multiple draws. | Syringe #1 Standard Deviation: 0.003893 mL |
| Syringe #2 Standard Deviation: 0.002582 mL |
Note: The document states, "Performance data demonstrated that the 3mL Syringe Keys facilitate the user in obtaining more accurate, precise and reproducible volume draws as compared to the standard method or visualization procedure." This statement, while lacking specific quantitative acceptance thresholds, indicates that the product performed favorably.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the example data provided (BD 3 mL Integra Syringes), 2 syringes were tested, and 10 draws were performed for each syringe. This means a total of 20 data points were presented as an example. The document also mentions, "Weight measurement analyses were conducted on each of the different 3 mL Syringe Keys multiple times," implying more extensive testing was conducted, but specific numbers for all syringe types aren't provided in the given excerpt.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It describes the testing as part of the "Performance Testing" for the 3mL Syringe Keys, suggesting it was conducted prospective to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an accessory for controlling syringe plunger travel and obtaining accurate volumetric withdrawals. The "ground truth" for its performance is directly measurable physical quantities (volume/weight). Therefore, no human experts were required to establish ground truth in the way typically seen in diagnostic AI studies. The ground truth was established by direct physical measurement using calibrated instruments (weighing dishes).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the ground truth was established through direct physical measurement, not expert opinion requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted as described in the document. This type of study is relevant for AI systems involving human interpretation, not for a mechanical accessory like the Syringe Keys.
- Effect Size: Not applicable. The device is a mechanical aid, not an AI system. The document does state, "Performance data demonstrated that the 3mL Syringe Keys facilitate the user in obtaining more accurate, precise and reproducible volume draws as compared to the standard method or visualization procedure," suggesting an unquantified improvement over manual methods. However, this is not an effect size derived from an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described appears to be a standalone (device-only) evaluation. The device's ability to control the plunger travel and facilitate accurate volume draws was tested directly by measuring the withdrawn liquid's weight. While a user operates the device, the core function tested is the device's mechanical precision in controlling the draw, rather than human interpretation or cognitive assistance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was direct physical measurement. The volume of withdrawn liquid was determined by weighing the liquid dispensed into "tarred weighing dishes" after being drawn from vials containing H₂O.
8. The sample size for the training set
Not applicable. This device is a mechanical accessory, not an algorithm that requires a "training set" in the context of machine learning or AI. The design process involved "establishing an empirical (not just mathematic) relationship of plunger travel to dispensed volume (weight)," which informed the physical design ("Syringe Key Design" worksheet). This is a design and calibration process, not an AI training process.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth for training in that context. The design was informed by empirical data relating plunger travel to dispensed volume, with ground truth for that initial empirical relationship established through direct physical measurement (weight).
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NOV 1 0 2011
Image /page/0/Picture/2 description: The image shows a logo for Xtract Solutions. The word "Xtract" is written in a bold, sans-serif font, with a syringe replacing the "I" in the word. Below the word "Xtract" is the word "Solutions" written in a smaller, sans-serif font. The logo is simple and modern, and the syringe suggests that the company is involved in the medical or pharmaceutical industry.
4.0 510(k) Summary (Prepared August 20, 2011):
In accordance with 21 CFR Section 807.92. Xtract Solutions. Is submitting the following 510(k) Summary:
4.1 Submitter Information -
Xtract Solutions 9495 SW Locust, Suite E Portland, OR 97223, USA FDA Registration No.: 3008292087 Owner / Operator No .: EIN 931264310
4.2 Preparer of Submission and Contact for Information -
Keith Lowrey, Vice President of Regulatory Affairs & Quality Assurance Xtract Solutions 9495 SW Locust Street, Suite E Portland, OR 97223 Date of Preparation: August 20, 2011
Contact Information for 510(k) Correspondence:
611 South Schoolhouse Creek Rd. Grants Pass, OR 97526 Office: 541-476-1628 Cell: 805-403-4676 E-mail: Lowrey_RA_QA_Soutions@yahoo.com
4.3 Name of Device -
- 4.3.1 Trade / Proprietary Name: Xtract 3mL Syringe Keys
- 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 Requlation Number: 21 CFR 880.5860
Product Code: 4.4.5 The product code for the Syringe Keys is FMF.
- 4.4.6 Class: Class II (performance standards)
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4.4 Substantial Equivalence -
This submission establishes the substantial equivalence of the Xtract Solutions 3mL Syringe Keys as an accessory to piston hypodermic syringes such as the following predicate device:
- 4.4.1 Xtract Solutions Syringe Keys, K091200, SE 08/21/2009, manufactured by Xtract Solutions, Portland, OR.
- Xtract Solutions has added to the "family of Xtract Solutions Syringe 4.4.2 Keys" four (4) additional Syringe Keys to accommodate 3 mL piston hypodermic syringes.
4.5 Description of the Device -
- The Xtract Solutions 3 mL Syringe Key is a hand held passive tool 4.5.1 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/Figure/7 description: The image shows two close-up shots of a white object with labels pointing to specific features. In the left shot, arrows point to the "TEETH" of the object. In the right shot, arrows point to the "GROOVE" and "NOTCH" of the object.
Figure 1 Teeth hold the finger grip of syringe. of the plunger.
Figure 2 The notch holds the end
- The 3 mL Syringe Key facilitates the user in obtaining rapid and 4.5.2 accurate volumetric with-drawls from vials containing vaccines and The Syringe Key has been re-designed for other medications. ergonomic improvement for the user and to fit four (4) additional piston hypodermic syringes:
- 3 mL VanishPoint (RTI10311) syringes, 23g x 1" .
- 3 mL BD SafetyGlide (BD305905) syringes, 23g x 1" .
- 3 mL BD Integra (BD305271) syringes 23g x 1" .
- 3 mL BD Precision Glide (BD309578) syringes 20g x 1" .
SECTION 4 PAGE 3
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- The 3 mL Syringe Key is 5 inches long and is curved to fit comfortably 4.5.3 in the user's hand.
4.5.4
Image /page/2/Picture/3 description: In the image, a hand is holding a white rectangular object. The hand is gripping the object firmly, with the fingers curled around it. The object appears to be made of a solid material, and it is reflecting light. The background is a plain surface.
Figure 3 Key is curved to provide ergonomic grip by user
- 4.5.5 At the top of the Key on the underside are three features:
Teeth: These raised points allow the user to pull out the syringe plunger easily.
Groove: The width of the groove corresponds to the type of syringe designated for the specific Key. * The length of the groove equates to the dose the Key will withdraw.
Notch: The notch holds the end of the plunger secure when pulling back and pushing forward to measure the dose.
Image /page/2/Picture/9 description: The image shows a three-step process of connecting a syringe to a device. Step 1 shows the syringe and device separated with labels pointing to the teeth, groove, and notch. Step 2 shows the syringe partially connected to the device. Step 3 shows the syringe fully connected to the device.
e 4 Key controls the distance the syringe plunger can be drawn through the syringe barrel
Figur
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- 4.5.5 The plunger is pulled slightly from the syringe barrel (Step 1) and the plunger thumb rest is then nested into a precise slot located at the proximal end of the Syringe Key (Step 2). After seating the thumb rest in the Syringe Key, the syringe's barrel is moved backward against the proximal flat face of the Syringe Key (Step 3).
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4.6 Indications for Use -
- The product family of Xtract Solutions Syringe Keys are indicated as accessories 4.6.1 provided for specified commercially available piston hypodermic syringes (for medical purposes) which are 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 other medications. The Syringe Keys (available for 1mL and/or 3 mL hypodermic syringes) are designed as an accessory only for the following syringes:
4.6.1.1 1 mL syringes:
- . 1 mL Terumo SurSaver Mixing Syringes (SS01A2313T) and/or
- 1 mL Greer Optimix (GROM-23) SurSaver Mixing Syringes. .
4.6.1.2 3 mL syringes:
- . 3 mL VanishPoint (RTI10311) Syringes, 23g x 1"
- 3 mL BD SafetyGlide (BD305905) Syringes, 23g x 1" .
- 3 mL BD Integra (BD305271) Syringes 23g x 1" .
- . 3 mL BD Precision Glide (BD309578) Syringes 20g x 1"
- The device assists the user in withdrawing precise and accurate liguid volume 4.6.2 withdraws from a vial. The Syringe Keys do not facilitate or assist the user with injecting the contents of the hypodermic syringe.
- The Syringe Keys can be used by medical personnel as well as individuals who 4.6.3 are not medical professionals: but, have been instructed in their use,
- Svringe Keys are available for specified piston hypodermic syringe models 4.6.4 manufactured by designated syringe manufacturers.
4.7 Specifications -
- 4.7.1 The 3mL Syringe Keys are designed and fabricated for use with the following specified piston hypodermic syringes and specified volume withdrawals:
- mL VanishPoint (RTI10311) Syringes, 23g x 1" .
- 3 mL BD SafetyGlide (BD305905) Syringes, 23g x 1" .
- 3 mL BD Integra (BD305271) Syringes 23g x 1 .
- . 3 mL BD Precision Glide (BD309578) Syringes 20g x 1"
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XTRACT Solutions, Syringe Keys 510(k) Submission, August 2011
Image /page/5/Picture/1 description: The image shows four different types of syringes. The first syringe is a B-D PrecisionGlide 3mL syringe with a reference number of 309578 and a volume of 1.50 mL. The second syringe is a B-D Integra 3mL syringe with a reference number of 305271 and a volume of 0.5 mL. The third syringe is a SafetyGlide 3 mL syringe with a volume of 0.5 mL, and the fourth syringe is a VanishPoint 3 mL syringe with a volume of 0.5 mL.
Figure 5 Examples of 3 mL Syringe Keys
- 4.7.2 The new 3mL Syringe Keys are designed for the following volume withdrawals:
| Safety GlideP/N 120-0003 | Vanish PointP/N 120-0002 | BD Precision GlideP/N 190-0101 | BD IntegraP/N 190-0110 |
|---|---|---|---|
| 0.5 mL | 0.5 mL | 0.5 mL | 0.5 mL |
- The Xtract Solutions 3mL Syringe Keys will be sold by prescription 4.7.4 only and labeling will bear the statement, "Caution: Federal Law restricts this device to sale by or on the order of a physician."
Technological Characteristics in Comparison to the Predicates -4.8
4.8.1 Predicate Device -
The Xtract Solutions 3mL Syringe Key is substantially equivalent to the Xtract Solutions 1mL Syringe Keys, K091200, SE 08/21/2009
Manufacturer: Xtract Solutions, Portland, OR 97223
4.8.2 Materials -
Materials used to fabricate the Xtract 3mL Syringe Keys are polycarbonate/ABS blend and/or Delrin® that have a long use in medical devices.
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4.8.3 Performance Comparison-
As an accessory for the hypodermic svringe, the 3mL Svringe Keys and the 1 mL Svringe Keys 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.
Performance Testing -4.9
- The 3mL Syringe Keys were designed by first establishing an 4.9.1 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 volume sizes for each 3 mL Syringe Key.
- 4.9.2 Upon receipt of the 3mL Syringe Keys, a First Article Inspection was performed to verify that all dimensions met drawing specifications and requirements as noted in following graph:
Example data: 3 mL Syringe Keys tested with BD 3 mL Integra Syringes:
| Dose Verification at DesignLength (0.578") | |||
|---|---|---|---|
| Syringe | # 1 | #2 | |
| DRAW | 1 | 0.502 | 0.504 |
| 2 | 0.503 | 0.506 | |
| 3 | 0.495 | 0.501 | |
| 4 | 0.499 | 0.499 | |
| 5 | 0.500 | 0.506 | |
| 6 | 0.505 | 0.502 | |
| 7 | 0.500 | 0.502 | |
| 8 | 0.493 | 0.500 | |
| 9 | 0.504 | 0.499 | |
| 10 | 0.503 | 0.501 | |
| AVG | 0.500 | 0.502 | |
| STD | 0.003893 | 0.002582 |
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The channel length measurements of the actual syringe keys and the "draw volumes" were evaluated and compared. Using the 3mL Syringe Keys, piston hypodermic syringes with needles were introduced into the septum of vials containing H₂0.
The liquid was withdrawn from the vials and dispensed into tarred weighing dishes and subsequently weighed. Weight measurement analyses were conducted on each of the different 3 mL Syringe Keys multiple times.
- 4.9.3 Performance data demonstrated that the 3mL Syringe Keys facilitate the user in obtaining more accurate, precise and reproducible volume draws as compared to the standard method or visualization procedure.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 0 2011
Xtract Solutions C/O Keith Lowrey Vice President of Regulatory Affairs & Quality Assurance 9495 SW Locust Street, Suite E Portland, Oregon 97223
Re: K112475
Trade/Device Name: Xtract Syringe Keys Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 26, 2011 Received: September 8, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. Lowery
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 V. Anston
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/10/Figure/1 description: The image shows the logo for Xtract Solutions. The logo is black and white and features a stylized "X" with a syringe in place of the "T" in Xtract. Below the word Xtract is the word Solutions in a smaller font.
INDICATIONS FOR USE STATEMENT
KI12475 510(k) Number (if known): To be determined by FDA .
Device Name: Xtract Svringe Kevs
Indications for Use:
- 1.1 The product family of Xtract Solutions Syringe Keys are indicated as accessories provided for specified commercially available piston hypodermic syringes (for medical purposes) which are designed to control the distance the syringe plunger can be drawn through the svringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and other medications. The Syringe Keys (available for 1mL and/or 3 mL hypodermic syringes) are designed as an accessory only for the following syringes:
- 1.1.1 1 mL svringes:
- 1 mL Terumo SurSaver Mixing Syringes (SS01A2313T) and/or .
- 1 mL Greer Optimix (GROM-23) SurSaver Mixing Syringes. .
- 1.1.1 1 mL svringes:
1.1.2 3 mL syringes:
- 3 mL VanishPoint (RTI10311) Syringes, 23g x 1" .
- 3 mL BD SafetyGlide (BD305905) Syringes, 23g x 1" .
- . 3 mL BD Integra (BD305271) Syringes 23g x 1"
- 3 mL BD Precision Glide (BD309578) Syringes 20g x 1" .
- 1.2 The device assists the user in withdrawing precise and accurate liquid volume withdraws from a vial. The Syringe Keys do not facilitate or assist the user with injecting the contents of the hypodermic syringe.
- 1.3 The Syringe Keys can be used by medical personnel as well as individuals who are not medical professionals; but, have been instructed in their use.
- 1.4 Syringe Keys will be available for specified piston hypodermic syringe models manufactured by designated syringe manufacturers.
| Prescription Use(Part 21 CFR 801 Subpart D | X |
|---|---|
| ------------------------------------------------ | --- |
AND/OR
| Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(Division Sign-GHFEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
| 510(k) Number: | K112475 | SECTION 3 PAGE 2 |
|---|---|---|
| Kature Loftused for Richard Chapman | ||
| 11/10/11 |
§ 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).