The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

Device Description

The Drug Access Spike is a plastic conduit that is a means to access drug containers. The device is center on top of the stopper of a drug container. The Drug Access Spike is pushed through the rubber stopper and locks into position. A syringe is attached to the Drug Access Spike in order to draw from the drug container. After detaching the syringe, solution/medications are dispensed into a needleless injection site. The use of a Drug Access Spike eliminates the need for a conventional needle.

On multi-dose containers, a needleless injection site is bonded to the Drug Access Spike. This allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress.

The needleless injection port incorporated into some of the configurations of the Drug Access Spike is the NAC " Needleless Access Connector. The NAC " Needleless Access Connector was previously cleared under SE-K011193 and SE-K992268.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medegen Medical Manufacturing Services Drug Access Spike, based on the provided 510(k) summary:

This device (Drug Access Spike) is a relatively simple medical accessory, and as such, the "acceptance criteria" and "study" are not presented in the same highly quantitative, performance-metric-driven way you might see for a diagnostic AI device. Instead, the submission focuses on substantial equivalence to legally marketed predicate devices, and the "proof" is demonstrating that the new device shares the same intended use and technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, for aspects related to "device performance" in the context of an AI-driven system, the information is largely absent or inferred, as it's not a diagnostic or decision-support tool.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (a drug access spike), the acceptance criteria are not in the form of specific performance metrics like sensitivity, specificity, or AUC, as would be common for AI-based diagnostic devices. Instead, they revolve around safety, functionality, and equivalence to existing devices.

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k))	Reported Device Performance (Summary)
Intended Use	Must aspirate solutions/medications from a drug container (vial/bag) and potentially aid in prevention of accidental needle sticks.	The device description and intended use statement confirm it is designed to "aspirate solutions/medications from a drug container (drug vial/bag)" and "may incorporate componentry that aid in the prevention of accidental needle sticks." This directly aligns with the broader intended use of the predicate devices.
Technological Characteristics	Must function as a plastic conduit pushed through a stopper, locking into position, and allowing syringe attachment and medication dispensing. The needleless injection port (if present) must function to allow multiple accesses while maintaining a physical barrier to microbial ingress.	The device is described as "a plastic conduit that is a means to access drug containers," "pushed through the rubber stopper and locks into position," and allows a "syringe to be attached... to draw from the drug container." For multi-dose configurations, it explicitly states a "needleless injection site is bonded to the Drug Access Spike... allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress." The NAC component was previously cleared under SE-K011193 and SE-K992268, indicating its established functionality and safety.
Biocompatibility	Materials must meet ISO 10993 Biocompatibility Requirements for External Communicating Devices, Indirect Blood Path.	"The materials used to manufacture the Drug Access Spike meet ISO 10993 Biocompatibility Requirements for External Communicating Devices, Indirect Blood Path." This is a direct statement of compliance.
Safety and Effectiveness	Must raise no new questions of safety or effectiveness compared to predicate devices.	Based on the FDA's decision to clear the device, it was deemed "substantially equivalent" to legally marketed predicate devices. This implicitly means the FDA found no new questions of safety or effectiveness were raised by the device's design, materials, or intended function compared to the predicates (ICU Medical's CLAVE Vial Access Spike (K934591), ICU Medical's One Time Vial Access Spike (K934561), and Baxter Healthcare Corp's Needle*Less Drug Vial Adapter (K894177)).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This device is a physical medical accessory, not an AI model that processes data or images. Performance is demonstrated through compliance with standards (biocompatibility) and functional description/comparison to predicates, rather than a data-driven "test set."
Data Provenance: Not applicable for an AI test set. The "provenance" here relates to the predicate devices themselves, which are legally marketed in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts & Qualifications: Not applicable. The "ground truth" for this device's safety and effectiveness is established by its compliance with recognized standards (ISO 10993), functional design, and comparison to existing, cleared devices. It does not involve expert review of data/images to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no diagnostic test set requiring adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This is not an imaging or diagnostic device that involves human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's approval is based on:
- Regulatory Standards Compliance: Demonstrated adherence to ISO 10993 for biocompatibility.
- Functional Equivalence: The described mechanism of action and intended use are directly comparable to those of the predicate devices.
- Predicate Device History: The predicate devices themselves have an established history of safety and effectiveness on the market.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI model with a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. This is not an AI model.

Summary of the "Study" (Rationale for Acceptance):

The "study" or basis for acceptance described in this 510(k) is a substantial equivalence demonstration. This process involves:

Identification of Predicate Devices: Three equivalent devices (from ICU Medical and Baxter Healthcare Corp) with established 510(k) clearances were identified.
Comparison of Intended Use: The applicant demonstrated that the Drug Access Spike shares the same intended use as the predicate devices.
Comparison of Technological Characteristics: The applicant detailed the physical design and function of the device, showing it operates similarly to the predicates. Specific mention of the previously cleared NAC component further supports this.
Biocompatibility Testing: The device's materials were tested to meet the ISO 10993 standard for biocompatibility, addressing a key safety aspect.
Conclusion of No New Questions of Safety or Effectiveness: By successfully demonstrating the above, the FDA concluded that the device is substantially equivalent to the predicates and raises no new questions of safety or effectiveness.

Summary

{0}------------------------------------------------

K051930

AUG 1 6 2005

510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

Name:	Medegen Medical Manufacturing Services
Address:	930 Wanamaker Ave.Ontario, CA 91761
CONTACT PERSON:	SALVADORE F. PALOMARES, RAC

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: Trade Name: Drug Access Spike Common Name: Accessory to Piston Syringe Classification Name: Same

Equivalent Devices:

Manufacturer:	ICU Medical	ICU Medical	Baxter Healthcare Corp
Name:	CLAVE Vial AccessSpike	One Time Vial AccessSpike	Needle*Less Drug VialAdapter
510(k) #:	K934591	K934561	K894177

Device Description:

Intended Use:

Biocompatibility:

The materials used to manufacture the Drug Access Spike meet ISO 10993 Biocompatibility Requirements for External Communicating Devices, Indirect Blood Path.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three lines representing the head, body, and legs. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the circle.

Public Health Service

AUG 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medegen Medical Manufacturing Services C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K051930

Trade/Device Name: Drug Access Spike Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Accessory Regulatory Class: II Product Code: FMF Dated: July 30, 2005 Received: August 1, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{2}------------------------------------------------

Page 2 - Mr. Job

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 or any I vatuall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premance noticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cures

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k):

ψsi934p

Device Name:

Drug Access Spike

The Drug Access Spike is a device used to aspirate Indications for Use: The Drug A60000 Opins from a drug container (drug solutions: The Drug Access Spike may incorporate vialibag). The Brag 7 in the prevention of accidental needle sticks.

Prescription Use
(Per 21 CFR 801 Subpart D)

Over the Counter Use AND/OR (21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Vmax

(Division Sign-Off) (Division Sign-Oll)
Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K951430

Regulation Number and Section

§ 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).