(217 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and usability, with no mention of AI or ML.
No
The device is described as an "anti-needlestick accessory" that assists in the safe removal of intraosseous needles and prevents accidental needle sticks. It does not treat or diagnose a disease or condition in a patient.
No
The device is an accessory designed to assist in the safe removal of intraosseous needles by preventing accidental needle sticks, not to diagnose a medical condition.
No
The device description clearly states it is a "single-use, non-sterile, antineedlestick accessory" and describes its physical mechanism for capturing a needle, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the safe removal of intraosseous needles, which is a procedure performed directly on a patient.
- Device Description: The device is an accessory for a medical procedure involving direct patient contact (intraosseous access).
- Anatomical Site: The device is used on specific anatomical sites on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on samples.
The device is a medical device used during a medical procedure on a patient, not a diagnostic test performed in vitro (outside the body).
N/A
Intended Use / Indications for Use
The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles.
IOSS is Indicated for Use with 25mm EZ-IO Vascular Access Needles and BD Luer-Lok 10mL Syringes.
Product codes
FMI
Device Description
The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, antineedlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is placed around the syringe and IO needle prior to removal from the patient. It irreversibly captures the IO needle within the device upon removal from the patient; helping to prevent accidental needle sticks to the patient or user. There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode.
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
Where used:
Pre-hospital
In hospital
Acute care
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)
Bench Performance Testing: Verification of Product Specification testing confirmed that the IO Needle Safety Sheath (IOSS) met all product specifications high temperature/humidity, and low temperature environmental conditions. Distribution testing conforming to ISTA 3A 2018 (FDA Recognition Number 5-126) confirmed that IOSS met all product specifications and acceptance criteria after being exposed to shipping and transportation conditions. Accelerated Shelf Life testing confirmed that IOSS met all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of up to 5 years.
Usability Testing: Human factors validation testing confirmed that the user population can safely and effectively use IOSS for the intended use in the expected use environment without encountering a needle stick, serious use errors, or other problems.
Biocompatibility Testing: IOSS is categorized as a limited duration surface device expected to normally contact intact skin, but which may incidentally contact breached or compromised skin. Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing was conducted on IOSS in its final finished form. All tests confirmed the suitability of IOSS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
October 31, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Actuated Medical, Inc Douglas Dillon Director, Quality Assurance & Regulatory Affairs 310 Rolling Ridge Drive Bellefonte, Pennsylvania 16823
Re: K220890
Trade/Device Name: IO Needle Safety Sheath Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 28, 2022 Received: September 29, 2022
Dear Douglas Dillon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220890
Device Name IO Needle Safety Sheath (IOSS)
Indications for Use (Describe)
The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles.
IOSS is Indicated for Use with 25mm EZ-IO Vascular Access Needles and BD Luer-Lok 10mL Syringes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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310 Rolling Ridge Drive Bellefonte, PA 16823 + p (814) 355-0003 + f (814) 355–1532
ActuatedMedical.com
Certified ...
-
- ISO 13485:2016
-
- Medical Device Single Audit Program (MDSAP)
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- Women's Business Enterprise (WBE)
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- Women-Owned Small Business (WOSB)
K 220890 510(k) SUMMARY
Applicant Information
Date Prepared: October 28, 2022
Name and Address: Actuated Medical, Inc. 320 Rolling Ridge Drive Bellefonte, PA 16823 Ph: (814) 355-0003 Fx: (814) 355-1523
Contact Person: Douglas R. Dillon Director, Quality Assurance and Regulatory Affairs Ph: (814) 355-0003 x107 Fx: (814) 355-1523 Email: Douglas.Dillon@actuatedmedical.com
Device Information
| Trade Name | IO Needle Safety Sheath (IOSS) |
|---|---|
| Common Name: | IO Needle Safety Sheath (IOSS) |
| Classification: | 21 C.F.R. §880.5570 |
| Classification Name: | Needle, Hypodermic, Single Lumen |
| Product Code: | FMI |
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Predicate Device
The legally marketed device to which substantial equivalence is being claimed:
| 510(k)
| Number | Trade Name | Submitter |
|---|---|---|
| K180395 | EZ-IO Intraosseous | |
| Vascular Access System | ||
| (EZ-IO) | Arrow International, Inc. | |
| (Subsidiary of Teleflex) |
Device Description
The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, antineedlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is placed around the syringe and IO needle prior to removal from the patient. It irreversibly captures the IO needle within the device upon removal from the patient; helping to prevent accidental needle sticks to the patient or user. There is tactile confirmation of capture, and the clear body of IOSS allows for visual confirmation that the IO needle is in Safe Mode.
Intended Use
IOSS is intended to assist in the safe removal of intraosseous needles.
Indications for Use
The IO Needle Safety Sheath (IOSS) is intended to assist in the safe removal of intraosseous needles. IOSS is indicated for use with 25mm and 45mm EZ-10® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe.
Technological Characteristics
Because IOSS is only used to remove the parent predicate device (EZ-IO) from the patient, substantial equivalence considerations are primarily focused on the removal of EZ-IO as compared to the removal of EZ-IO with IOSS. The contraindications, target population, and anatomical sites used are identical to the predicate device. Key differences between the predicate and IOSS include needle removal technique, required accessories, sterility, patient contact, and materials of construction.
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Image /page/5/Picture/1 description: The image is an abstract background with a pattern of orange squares and a wavy line design. The squares are arranged in a grid-like fashion, with alternating shades of orange to create a subtle contrast. The wavy lines are also orange and appear to be overlaid on top of the squares, adding a dynamic element to the design. The overall effect is a visually interesting and textured background.
| Category | Predicate EZ-IO | Proposed IOSS Used as
Indicated with Predicate
Device | Comparison |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | For intraosseous access
anytime in which vascular
access is difficult to obtain
in emergent, urgent, or
medically necessary cases
for up to 24 hours. Insertion
sites: ADULTS (≥22 years
old): proximal humerus,
proximal tibia, distal tibia.
PEDIATRICS (≤21 years
old): proximal humerus,
proximal tibia, distal tibia,
distal femur.
Use of the device may be
extended for up to 48 hours
when alternate intravenous
access is not available or
reliably established.
Insertion sites:
ADULTS (≥22 years):
proximal humerus, proximal
tibia, distal tibia.
PEDIATRICS (≥12 years
through 21 years old):
proximal humerus, proximal
tibia, distal tibia, distal
femur. | The IO Needle Safety
Sheath (IOSS) is intended
to assist in the safe removal
of intraosseous needles.
IOSS is Indicated for Use
with 25 mm and 45 mm EZ-
IO® Vascular Access
Needles and BD Luer-
Lok™ 10 mL Syringes. | Different -
Indications for
the same
intended use
and a subset of
the available
needle sets
does not raise
new questions
of safety or
efficacy. |
| Category | Predicate EZ-IO | Proposed IOSS Used as
Indicated with Predicate
Device | Comparison |
| Needle
removal
technique | Remove any extension sets
and dressings.
Attach a luer-lock syringe to
the hub of the catheter.
While maintaining
alignment of the needle and
the syringe, the syringe is
rotated clockwise while
pulling straight up. Rocking
or bending the catheter
upon removal should be
avoided. | Remove any extension sets
and dressings.
Attach a BD Luer-Lok 10
mL Syringe to the hub of
the catheter.
Latch IOSS around the
syringe. Hold IOSS in place
with one hand.
While maintaining
alignment of the needle and
the syringe, the syringe is
rotated clockwise while
pulling straight up until the
EZ-IO hub locks in Safe
Mode. Rocking or bending
the catheter upon removal
should be avoided. | Different -
Adding the use
of IOSS into
the removal
process is a
difference. It
does not raise
new questions
of safety or
efficacy. |
| Disposal | Dispose of the catheter with
the syringe attached in an
approved sharps container. | Dispose of catheter with the
syringe attached and
covered by IOSS
immediately after use in an
approved sharps container. | Same |
| Required
accessories | Luer-lock syringe (not
included) to use as handle
for removal of needle. | IOSS indicated only for one
specific syringe: BD Luer-
Lok™ 10 mL Syringe (not
included) to use as handle
for removal of needle. | Same |
| Contra-
indications | · Fracture in target bone.
· Previous, significant
orthopedic procedure at the
site, prosthetic limb or joint.
· IO access (or attempted
IO access) in targeted bone
within past 48 hours.
• Infection at the area of
insertion.
· Excessive tissue (severe
obesity) and/or absence of
adequate anatomical
landmarks. | Unchanged | Same |
| Category | Predicate EZ-IO | Proposed IOSS Used as
Indicated with Predicate
Device | Comparison |
| Target
population | Adult and pediatric patients
who are in need of vascular
access. | Unchanged | Same |
| Where used | Pre-hospital
In hospital
Acute care | Unchanged | Same |
| Anatomical
sites used | Proximal Humerus
Proximal Tibia
Distal Tibia
Distal Femur (pediatrics
only) | Unchanged | Same |
| Needle/
Cannula
design | Sterile, single use
Hubs: colored
polycarbonate
Stylet/catheter: Stainless
Steel
Faceted tip
Standard luer connection
Three lengths:
15 mm; 25 mm; 45 mm
Size: 15 gauge (0.071", 1.8
mm)
Needle Cover:
Polypropylene | Device has no
needle/cannula. | Different -
IOSS assists in
the safe
removal
intraosseous
needles. |
| Needle set
quidelines | Available Needle Sets:
15 mm: 3-39 kg
25 mm: 3 kg or over
45 mm: 40 kg or over | Indicated for Needle Sets:
IOSS only indicated for the
25 mm and 45 mm Needle
Sets | Different -
IOSS only
indicated for
the 25 mm and
45 mm Needle
Sets due to 15
mm Needle
design. |
| Depth control | Positioning marks at 5 cm
and 10 cm apart to provide
visual reference points
Tactile feedback for change
of pressure | Unchanged. | Same |
| Single use
components/
accessories | EZ-IO Needle Sets
EZ-Connect Extension Set
EZ-IO Patient Wristband
EZ-Stabilizer Dressing | BD Luer-Lok™ 10 mL
Syringe | Different -
IOSS only
requires a
syringe for use. |
| Sterility | Sterile: Ethylene Oxide | IOSS is non-sterile. | Different -
Patient contact
for IOSS does
not require
sterilization. |
| Category | Predicate EZ-IO | Proposed IOSS Used as
Indicated with Predicate
Device | Comparison |
| Shelf life | 4 Years | 5 years | Different -
Additional year
of shelf life
does not raise
new questions
of safety or
efficacy. |
| Bio-
compatibility | Biocompatible materials
used (per ISO 10993-1
prolonged contact
duration). | Biocompatibility of IOSS
established per ISO 10993-
1 for limited duration
surface contact:
Cytotoxicity, Sensitization,
Irritation, Pyrogenicity, and
Systemic Toxicity | Different -
IOSS and
Predicate both
meet
biocompatibility
endpoints
appropriate for
their patient
contact. |
| Materials of
construction | Stainless steel catheter,
polycarbonate and color
additive hubs, and
polypropylene needle
cover. | Clear, colorless, INEOS K-
Resin KR01 styrene
butadiene block copolymer | Different -
different
materials meet
all
requirements
for
biocompatibility
and physical
properties:
raising no new
questions of
safety or
efficacy. |
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Image /page/7/Picture/1 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange, transitioning from a lighter shade to a darker one. Overlaid on this background is a pattern of plus signs, arranged in a grid-like fashion, with the color of the plus signs alternating between the two shades of orange. A series of wavy lines are superimposed on the plus sign pattern, adding a sense of movement and fluidity to the design.
8
Non-Clinical Performance Data
The methods and performance data for evaluating the technological differences, the questions of safety and effectiveness, as well as IOSS integrity and compatibility with the predicate device (EZ-IO) include bench performance testing, usability testing, and biocompatibility testing.
Bench Performance Testing: Verification of Product Specification testing confirmed that the IO Needle Safety Sheath (IOSS) met all product specifications high temperature/humidity, and low temperature environmental conditions. Distribution testing conforming to ISTA 3A 2018 (FDA Recognition Number
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Image /page/9/Picture/1 description: The image is an abstract design featuring shades of orange. The background consists of a pattern of squares in two slightly different shades of orange, creating a checkerboard effect. A wavy line, also in orange, meanders across the pattern, adding a dynamic element to the design.
5-126) confirmed that IOSS met all product specifications and acceptance criteria after being exposed to shipping and transportation conditions. Accelerated Shelf Life testing confirmed that IOSS met all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of up to 5 years.
| Test Performed | Test Description | Standards
Organization and
Designation | Results |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------|
| Biocompatibility | Final, finished devices tested for
cytotoxicity, sensitization, irritation or
intracutaneous reactivity, acute
systemic toxicity, and material
mediated pyrogenicity. | ISO 10993-12, 2021
ISO 10993-5, 2009
ISO 10993-10, 2010
ISO 10993-23, 2021
ISO 10993-11, 2017 | Pass |
| Verification of
Product
Specification | Verification of Product Specifications
after exposure to ambient, high
temp/humidity, and low temperature
environmental conditions. | NA | Pass |
| Usability | A total of 500 uses by thirty (30)
Users to assess whether the
intended user population can use
IOSS without encountering a needle
stick, serious use errors, or problems
for the intended use and expected
use environment. | NA | Pass |
| Distribution | Confirmation of Product
Specifications following exposure to
simulated distribution stress and
conditions. | ISTA 3A 2018 | Pass |
| Accelerated
Shelf Life | Confirmation of Product
Specifications following exposure
accelerated conditions simulating a
shelf life of one (1), three (3), and five
(5) years. | NA | Pass |
| Shelf Life | Confirmation of Product
Specifications following real-time
ambient condition exposure for one
(1), three (3), and five (5) years. | NA | Test on-going. |
Usability Testing: Human factors validation testing confirmed that the user population can safely and effectively use IOSS for the intended use in the expected use environment without encountering a needle stick, serious use errors, or other problems.
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Image /page/10/Picture/1 description: The image is an abstract design featuring a combination of geometric shapes and wavy lines. The color palette is dominated by shades of orange, with a lighter orange used for the wavy lines and some of the geometric shapes, creating a contrast against the darker orange background. The geometric shapes appear to be arranged in a grid-like pattern, adding a structured element to the design. The wavy lines overlay the geometric shapes, introducing a sense of movement and fluidity to the overall composition.
Biocompatibility Testing: IOSS is categorized as a limited duration surface device expected to normally contact intact skin, but which may incidentally contact breached or compromised skin. Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing was conducted on IOSS in its final finished form. All tests confirmed the suitability of IOSS.
Conclusions
After evaluating IOSS for its intended use with EZ-IO (the predicate device), then identifying, evaluating, and mitigating the risks associated with both use and foreseeable misuse where practicable, and confirming the safety and effectiveness of the device was through worst-case testing, it is concluded that IOSS is as safe and effective as EZ-IO when used as indicated to remove EZ-IO 25 mm and 45 mm intraosseous needles.