AccuSert Needle Inserter

K213429 · Emed Technologies Corporation · KZH · Oct 20, 2022 · General Hospital

Device Facts

• Record ID: K213429
• Device Name: AccuSert Needle Inserter
• Applicant: Emed Technologies Corporation
• Product Code: KZH · General Hospital
• Decision Date: Oct 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2

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.

Device Story

AccuSert Needle Inserter is a manually operated, reusable, spring-loaded device designed to assist in the insertion of EMED subcutaneous infusion administration sets. The device consists of a polycarbonate housing, Delrin needle carrier, 304 stainless steel spring, and ABS plastic release button. Operation involves the user seating an infusion set onto the carrier, pushing the handle to compress the internal spring until it locks, placing the device against the skin, and activating a recessed trigger button. The spring mechanism drives the carrier to insert the needle into subcutaneous tissue at a 90-degree angle. Used in home or hospital environments by patients or clinicians. The device is designed for a 1-year usable life (550 cycles). It provides a consistent insertion method, potentially reducing user error and improving the reliability of subcutaneous access compared to manual insertion.

Clinical Evidence

No clinical study included. Evidence consists of bench testing and usability evaluation. Biocompatibility testing performed per ISO 10993-1 (Chemical Characterization, Cytotoxicity, Sensitization, Skin Irritation). Design verification included cocking force, trigger force, insertion force, life cycle testing (550 cycles), chemical resistance, and drop testing per ISO 28620:2020. Usability evaluation conducted per ANSI/AAMI HE75:2009 and IEC 62366-1 confirmed intended users can operate the device safely and effectively.

Technological Characteristics

Manually operated, spring-loaded mechanical inserter. Materials: Polycarbonate housing, Delrin needle carrier, 304 stainless steel spring, ABS release button. Dimensions: 1.65in x 1.41in x 4.03in; Weight: 36.6g. Non-sterile; manual cleaning. Standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-18, ISO 10993-23, ANSI/AAMI HE75, IEC 62366-1, ISO 28620.

Indications for Use

Indicated for patients requiring subcutaneous administration of medication via EMED needle sets; intended for use in home or hospital settings to assist 90-degree needle insertion. Single patient use only.

Regulatory Classification

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.

Predicate Devices

• Sil-Serter Inserter (K010377)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: [phone] ext. 114 Fax: [phone] Email: [e-mail]

#### 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<br>(K010377) | EMED Accusert Needle<br>Inserter | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Indications for<br>Use | The Silserter infusion set<br>insertion system is intended<br>as an aid for insertion of the<br>Silhouette family of infusion<br>sets.<br>Single patient use only. | AccuSert Needle Inserter is<br>intended for use at home or<br>hospital environment to assist<br>inserting EMED subcutaneous<br>administration needle sets into<br>the subcutaneous tissue at<br>90 degrees.<br>Single patient use only. | Insignificant difference (See<br>NOTE 1 below). |
| Prescription or<br>Over the<br>Counter | Prescription | Prescription | SAME |
| Environment of<br>Use | Home use | Home and Hospital Use | Insignificant difference (see<br>NOTE 2 below) |
| Material(s) | Housing: ABS Plastic<br>Carrier: Nylon<br>Barrel: ABS Plastic<br>Springs: 302 Stainless Steel<br>Release buttons: Nylon<br>Damper ring: Thermoplastic<br>Elastomer (TPE)<br>Trigger button:<br>Polycarbonate<br>Bonding Solvent:<br>Cyclohexanone | Housing: Polycarbonate<br>Needle Carrier: Delrin<br>Springs: 304 Stainless Steel<br>Release button: ABS Plastic | Insignificant difference (see<br>NOTE 3 below) |
| Dimensions<br>(l x h x d) and<br>Weight | Approximately<br>6.75in x 1.43in x 1.43in<br>Weight not specified. | 1.65in x 1.41in x 4.03in<br>36.6 grams (0.08 lbs.) | Insignificant difference (see<br>NOTE 4 below) |
| Principle of<br>Action | Manually Operated | Manually Operated | SAME |
| Pressure Source | Spring-loaded | Spring-loaded | SAME |
| Safety<br>Feature(s) | Device release button locking<br>mechanism to prevent<br>accidental discharge. Carrier<br>tabs to maintain traveling<br>distance of 1.69in. and<br>insertion distance. | Recessed released button<br>mechanism to prevent accidental<br>discharge. Carrier stop to<br>maintain traveling distance of<br>1.19in. | Insignificant difference (see<br>NOTE 5 below) |
| Device<br>Performance | Designed to withstand 600<br>cycles | Designed to withstand 550<br>cycles | Insignificant difference (see<br>NOTE 6 below) |
| Cocking Force | Less than 7 lbf | 9-7 lbf | Insignificant difference (see<br>NOTE 7 below) |
| Trigger/Release<br>Force | Less than 7 lbf | Less than 7 lbf | SAME |

| Table 5-1: Comparison of Technological Characteristics with Predicates | | |
|------------------------------------------------------------------------|--|--|
| | | |

{5}------------------------------------------------

| Parameter | Sil-Serter Inserter<br>(K010377) | EMED Accusert Needle<br>Inserter | Comparison |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Insertion Force | 1.67 lbf | 1.0 -2.5 lbf | Insignificant difference (see<br>NOTE 8 below) |
| Biocompatibility | Not applicable. The device<br>does not come into direct<br>contact with blood or body<br>fluids. Momentary limited<br>skin contact. | The battery of testing included:<br>• Chemical Characterization<br>• Cytotoxicity<br>• Sensitization<br>• Skin Irritation | Insignificant difference (see<br>NOTE 9 below) |
| Sterility | Non-Sterile | Non-Sterile | SAME |
| Validated<br>Cleaning<br>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.