(364 days)
Not Found
No
The device description explicitly states it is a "manually operated, reusable, spring-loaded injection device" and there are no mentions of AI, ML, or related technologies in the provided text.
No
The device is used to assist in the insertion of needles for subcutaneous administration, it does not directly treat or diagnose a disease or condition itself.
No
The device is used to assist in the insertion of needles for subcutaneous administration, not to diagnose a condition or disease.
No
The device description explicitly states it is a "manually operated, reusable, spring-loaded injection device" consisting of a "plastic body containing a stainless-steel spring and a needle carrier component," indicating it is a physical hardware device.
Based on the provided information, the AccuSert Needle Inserter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- AccuSert Needle Inserter Function: The AccuSert Needle Inserter is a mechanical device used to insert a needle into the subcutaneous tissue of a patient. It is a tool used on the body, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "assisting inserting EMED subcutaneous administration needle sets into the subcutaneous tissue". This is a procedure performed directly on a patient.
Therefore, the AccuSert Needle Inserter falls under the category of a medical device used for administering substances or accessing the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
KZH
Device Description
The EMED AccuSert Needle Inserter is a manually operated, reusable, spring-loaded injection device. This device is used to insert EMED subcutaneous infusion administration sets. The device is contraindicated for use with other sets. The AccuSert Needle Inserter consists of a plastic body containing a stainless-steel spring and a needle carrier component.
The user places and securely seats the infusion set onto the carrier. The administration set is then loaded and locked into the AccuSert by pushing the needle carrier handle (thereby compressing the internal spring) until the carrier clicks/locks into place. The AccuSert is placed in contact with the intended insertion site and activated to release the infusion set at a 90° angle. The spring drives the carrier and the infusion set needle is inserted into the users' subcutaneous tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or hospital environment
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)
No clinical study is included in this submission.
The following performance data were provided in support of the substantial equivalence determinations:
Biocompatibility
The biocompatibility evaluation was conducted in accordance with the international standard EN ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within A Risk Management Process" as recognized by FDA. The battery of testing included the following:
- Chemical Characterization (ISO 10993-18:2020 Biological evaluation of medical . devices - Part 18: Chemical characterization of medical device materials within a risk management process)
- . Cytotoxicity (ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 testing for in vitro cytotoxicity)
- Sensitization (ISO 10993-10:2021 Biological evaluation of medica devices Part 10 • tests for skin sensitization)
- Skin Irritation (ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 tests for irritation)
The AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation.
Design Verification
Various performance tests were conducted to provide objective evidence that the device retains its mechanical properties and functions with EMED subcutaneous administration needle sets which include:
- Cocking Force .
- . Trigger Force
- Insertion Force •
- Visual/Functional
- . Life Cycle testing
- . Chemical Resistance
- Drop Test
- Cleaning
- Usability Evaluation
The aforementioned tests were completed compliant with the following standards:
- ANSI/AAMI HE75:2009 (R2018) Human Factors Engineering Design of Medical ● Devices
- IEC 62366-1:2015 Medical devices part 1, Application of usability engineering to medical devices
- ISO 28620:2020 Medical devices Non-electrically driven portable infusion devices . (Standard used to perform the Drop Test)
Results from performance testing indicate that the product meets the established performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 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.
October 20, 2022
Emed Technologies Corporation Olena Whalen QA/RA/CA Manager 1262 Hawks Flight Ct. Ste. 200 El Dorado Hills, California 95762
Re: K213429
Trade/Device Name: AccuSert Needle Inserter Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: Class II Product Code: KZH Dated: September 6, 2022 Received: September 13, 2022
Dear Olena Whalen:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213429
Device Name AccuSert Needle Inserter
Indications for Use (Describe)
AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K213429 510(k) Summary
Date Prepared: October 20, 2022
I. SUBMITTER
EMED Technologies Corporation 1262 Hawks Flight Ct El Dorado Hills, CA 95762
Contact Person: Olena Whalen Contact Person Title: OA/RA/CA Manager Tel: 916.932.0071 ext. 114 Fax: 916.932.0074 Email: owhalen@emedtc.com
II. DEVICE
Trade Name: AccuSert Needle Inserter Common or Usual Name: Introducer, Syringe Needle Classification Name: Syringe needle introducer Regulation Number: 21 CFR §880.6920 Product Code: KZH
III. PREDICATE DEVICE
(K010377), Sil-Serter Inserter (Product Code - KZH)
IV. DEVICE DESCRIPTION
The EMED AccuSert Needle Inserter is a manually operated, reusable, spring-loaded injection device. This device is used to insert EMED subcutaneous infusion administration sets. The device is contraindicated for use with other sets. The AccuSert Needle Inserter consists of a plastic body containing a stainless-steel spring and a needle carrier component.
The user places and securely seats the infusion set onto the carrier. The administration set is then loaded and locked into the AccuSert by pushing the needle carrier handle (thereby compressing the internal spring) until the carrier clicks/locks into place. The AccuSert is placed in contact with the intended insertion site and activated to release the infusion set at a 90° angle. The spring drives the carrier and the infusion set needle is inserted into the users' subcutaneous tissue.
V. INTENDED USE/INDICATIONS FOR USE:
AccuSert Needle Inserter is intended for use at home or hospital environment to assist inserting EMED subcutaneous administration needle sets into the subcutaneous tissue at 90 degrees. Single patient use only.
4
VI. TECHNOLOGICAL COMPARISON WITH PREDICATE DEVICE
The AccuSert Needle Inserter is not based on new technology, nor is it based on new clinical application of an existing technology. The device is based on well-established technology that has existed for decades; any advances or improvements are the result of incremental change of the existing technology in which design enhancements were enacted in an effort to improve safety, appearance, and usability, as well as to allow for physical compatibility with proprietary EMED administration set design characteristics and performance requirements.
| Parameter | Sil-Serter Inserter
(K010377) | EMED Accusert Needle
Inserter | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Indications for
Use | The Silserter infusion set
insertion system is intended
as an aid for insertion of the
Silhouette family of infusion
sets.
Single patient use only. | AccuSert Needle Inserter is
intended for use at home or
hospital environment to assist
inserting EMED subcutaneous
administration needle sets into
the subcutaneous tissue at
90 degrees.
Single patient use only. | Insignificant difference (See
NOTE 1 below). |
| Prescription or
Over the
Counter | Prescription | Prescription | SAME |
| Environment of
Use | Home use | Home and Hospital Use | Insignificant difference (see
NOTE 2 below) |
| Material(s) | Housing: ABS Plastic
Carrier: Nylon
Barrel: ABS Plastic
Springs: 302 Stainless Steel
Release buttons: Nylon
Damper ring: Thermoplastic
Elastomer (TPE)
Trigger button:
Polycarbonate
Bonding Solvent:
Cyclohexanone | Housing: Polycarbonate
Needle Carrier: Delrin
Springs: 304 Stainless Steel
Release button: ABS Plastic | Insignificant difference (see
NOTE 3 below) |
| Dimensions
(l x h x d) and
Weight | Approximately
6.75in x 1.43in x 1.43in
Weight not specified. | 1.65in x 1.41in x 4.03in
36.6 grams (0.08 lbs.) | Insignificant difference (see
NOTE 4 below) |
| Principle of
Action | Manually Operated | Manually Operated | SAME |
| Pressure Source | Spring-loaded | Spring-loaded | SAME |
| Safety
Feature(s) | Device release button locking
mechanism to prevent
accidental discharge. Carrier
tabs to maintain traveling
distance of 1.69in. and
insertion distance. | Recessed released button
mechanism to prevent accidental
discharge. Carrier stop to
maintain traveling distance of
1.19in. | Insignificant difference (see
NOTE 5 below) |
| Device
Performance | Designed to withstand 600
cycles | Designed to withstand 550
cycles | Insignificant difference (see
NOTE 6 below) |
| Cocking Force | Less than 7 lbf | 9-7 lbf | Insignificant difference (see
NOTE 7 below) |
| Trigger/Release
Force | Less than 7 lbf | Less than 7 lbf | SAME |
| Table 5-1: Comparison of Technological Characteristics with Predicates | ||
|---|---|---|
5
| Parameter | Sil-Serter Inserter
(K010377) | EMED Accusert Needle
Inserter | Comparison |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Insertion Force | 1.67 lbf | 1.0 -2.5 lbf | Insignificant difference (see
NOTE 8 below) |
| Biocompatibility | Not applicable. The device
does not come into direct
contact with blood or body
fluids. Momentary limited
skin contact. | The battery of testing included:
• Chemical Characterization
• Cytotoxicity
• Sensitization
• Skin Irritation | Insignificant difference (see
NOTE 9 below) |
| Sterility | Non-Sterile | Non-Sterile | SAME |
| Validated
Cleaning
Method | Manual | Manual | SAME |
| Usable Life | 1 year | 1 year | SAME |
NOTE 1: The Indications for Use statement for the AccuSert Needle Inserter are not identical to the predicate device. However, the differences do not affect the intended use of the device, nor does it affect the safety and effectiveness of the device relative to the predicate. Both devices are intended to aid in the insertion of specific infusion sets. Both the predicate and subject AccuSert Needle Inserter are indicated for single patient, multi-use. The insertion of the needle into subcutaneous tissue at 90 degrees is achieved through the design of the needle of the infusion set and not the design of the AccuSert Needle Inserter.
NOTE 2: The use of AccuSert Needle Inserter in the hospital or home environment does not have any impact on the safety or effectiveness of the device as there is no special training needed to use the device. The conducted Human Factors Validation Testing serve as objective evidence that the instructions for use provide the user with sufficient information to understand how the device is used.
NOTE 3: There are no bonding solvents or glues used in AccuSert Needle Inserter. The materials that compose the AccuSert Inserter were identified for their durability and performance characteristics. The plastics selected are widely used for medical device applications. The slight differences in the materials do not raise any new safety or effectiveness questions. The performance testing (biocompatibility and design verification) conducted on AccuSert Needle Inserter demonstrates the device functions as intended.
NOTE 4: The devices' form factor is different in design for the specific needle sets. The size and/or weight difference does not impact portability, usability, safety or the intended function, as both devices can insert the corresponding needle set into the skin.
NOTE 5: Both devices are designed to prevent accidental discharge. The minor difference in traveling distance do not have an impact to safety, performance, or effectiveness as both devices were designed and tested to insert the specific infusion needle sets into the skin. The AccuSert was designed with an adequate traveling distance to insert the intended needle set while maintaining small form factor design.
NOTE 6: The specified usable life for the AccuSert Needle Inserter and predicate are very similar: 550 cycles and 600 cycles, respectively. This is a minor difference that does not indicate any reasonable difference in technology, performance, or safety of the devices. The number of
6
simulated uses for the AccuSert Needle Inserter includes data derived from testing of multiple Inserters as well as performance testing to validate expected usable life duration.
NOTE 7: The predicate and subject devices operate in the same operational principle - the user must load the infusion set into the device, compress a spring and activate the device by pressing a trigger button. The force needed to load the AccuSert Needle Inserter and activate the release trigger were validated as appropriate though Usability Validation that demonstrated that the intended users could use the device safely and effectively without user errors or difficulties that could cause harm.
NOTE 8: The predicate and subject devices operate in the same operational principle - the user must load the infusion set into the device, compress a spring and activate the device by pressing a trigger button. With the subject device (AccuSert Needle Inserter) the needles are inserted into the skin using slightly lower spring force than the predicate device. However, the slight difference in spring force does not have a safety or effectiveness impact. The AccuSert was designed with adequate force to insert the intended needle sets with the minimum force and impact to the patient skin as confirmed by conducted performance testing
NOTE 9: The AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation
NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS VII.
No clinical study is included in this submission.
The following performance data were provided in support of the substantial equivalence determinations:
Biocompatibility
The biocompatibility evaluation was conducted in accordance with the international standard EN ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within A Risk Management Process" as recognized by FDA. The battery of testing included the following:
- Chemical Characterization (ISO 10993-18:2020 Biological evaluation of medical . devices - Part 18: Chemical characterization of medical device materials within a risk management process)
- . Cytotoxicity (ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 testing for in vitro cytotoxicity)
- Sensitization (ISO 10993-10:2021 Biological evaluation of medica devices Part 10 • tests for skin sensitization)
- Skin Irritation (ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 tests for irritation)
The AccuSert Needle Inserter has been evaluated for biocompatibility and is acceptable for its intended use by Biological Evaluation.
7
Design Verification
Various performance tests were conducted to provide objective evidence that the device retains its mechanical properties and functions with EMED subcutaneous administration needle sets which include:
- Cocking Force .
- . Trigger Force
- Insertion Force •
- Visual/Functional
- . Life Cycle testing
- . Chemical Resistance
- Drop Test
- Cleaning
- Usability Evaluation
The aforementioned tests were completed compliant with the following standards:
- ANSI/AAMI HE75:2009 (R2018) Human Factors Engineering Design of Medical ● Devices
- IEC 62366-1:2015 Medical devices part 1, Application of usability engineering to medical devices
- ISO 28620:2020 Medical devices Non-electrically driven portable infusion devices . (Standard used to perform the Drop Test)
Results from performance testing indicate that the product meets the established performance requirements.
VIII. FINAL CONCLUSION:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K010377.