The SwannShidi Bone Marrow Aspiration Needle consists of a 15ga needle and an angled tip stylet of corresponding size. A depth gauge with graduated scale and additional locking mechanism allows for adjustment of the penetration section of the needle. A luer lock connection is provided to allow aspiration of bone marrow or autologous blood by use of a standard surgical syringe. The SwannShidi is a single use, disposable device that will be supplied sterile.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device called the "SwannShidi Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as one might find for novel AI-powered diagnostic devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this 510(k) submission.

Here's why and what information is provided:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The 510(k) process for this type of device does not typically involve pre-defined acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy. Instead, substantial equivalence is demonstrated by comparing the new device's design, materials, intended use, and operational principles to legally marketed predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. No clinical test set data or studies are presented. The submission relies on a comparison table to predicate devices.

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):

Not Applicable. There is no test set or ground truth established in this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No test set involved.

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:

Not Applicable. This device is a manual aspiration needle, not an AI-powered diagnostic tool. MRMC studies would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable. No ground truth needed as no diagnostic performance claim is being made.

8. The sample size for the training set:

Not Applicable. This is not an AI-powered device and therefore does not have a training set.

9. How the ground truth for the training set was established:

Not Applicable. No training set.

What the document does provide in lieu of performance criteria and studies:

The document focuses on demonstrating Substantial Equivalence to legally marketed predicate devices. This is achieved by comparing various attributes of the SwannShidi Bone Marrow Aspiration Needle to its predicates:

Intended Use: The SwannShidi is for "aspiration of bone marrow or autologous blood by use of a standard syringe." This is shown to be substantially equivalent to the predicates, which also involve bone marrow aspiration.
Design Features: The device consists of a 15ga needle, angled tip stylet, depth gauge, locking mechanism, and a luer lock connection. These features are compared visually and descriptively to the predicates.
Materials: Stainless steel for the needle/stylet and medical-grade plastic for plastic components are consistent with predicate devices.
Sterilization Method: Ethylene Oxide is the chosen method, which is also consistent with predicates.
Minor Technological Differences: The submission explicitly states, "The minor technological differences between the SwannShidi and its predicate devices raise no issues of safety and effectiveness."

Predicate Comparison Summary Table:

The table explicitly compares the SwannShidi to three predicate devices (Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle, H.S. Hospital Service BMN "I" Type Marrow Biopsy Needle, and Ranfac Goldenberg SNARECOIL Needle) across several criteria:

Product Code: KNW (consistent for all except Ranfac which also lists FCG)
Regulation Name: Gastroenterology-urology biopsy instrument (consistent across all)
Intended Use: Similar for all, focusing on bone marrow aspiration/biopsy.
Needle Size: 15 gauge (consistent with Busse and H.S.; Ranfac has a range including 15g)
Stylet, Angled Tip, Male luer connection: All "Yes" and consistent with predicates.
Material (Needle/Stylet, Plastic Components): Stainless Steel and Medical Grade Plastic, consistent with predicates.
Sterilization Method: Ethylene Oxide, consistent with predicates.

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are effectively that the device is substantially equivalent in safety and effectiveness to existing legally marketed predicate devices, and the "study" demonstrating this is a direct comparison of features and intended use rather than a clinical performance study.

Summary

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K121181

510(k) Summary

Summary of 510(k) Safety and Effectiveness

Submitted By:

Alliance Partners, LLC 121 Interpark Blvd, #601 San Antonio, TX 78216

Date:

August 13. 2012

Jennifer Palinchik Regulatory Consultant

(440) 933-8850

Contact Person:

Contact Telephone:

Device Trade Name: Device Classification Name: Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device:

SwannShidi Bone Marrow Aspiration Needle Gastroenterology-urology biopsy instrument Class II Gastroenterology/Urology 876.1075 KNW Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle (K061570) H.S. Hospital Service S.p.A. BMN "I" Type Marrow Biopsy Needle (K020987) Ranfac Corporation Goldenberg SNARECOIL Needle (K031344)

Device Description:

Intended Use:

The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

Substantial Equivalence Information:

The design features, principles of operation, materials, indications for use, biocompatibility, and sterilization method of the SwannShidi are substantially equivalent to the predicate devices listed

AUG 2222012

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K121181 Page 2 of 2

above. The minor technological differences between the SwannShidi and its predicate devices raise no issues of safety and effectiveness.

Predicate Comparison Summary Table:

Item	SwannShidi	Busse HospitalDisposables I-Style BoneMarrow	H.S. HospitalService BMN"I" TypeMarrow Biopsy	RanfacGoldenbergSNARECOILNeedle
		AspirationNeedle	Needle
ProductCode	KNW	KNW	KNW	KNW, FCG
RegulationName	Gastroenterology-urology biopsyinstrument	Gastroenterology-urology biopsyinstrument	Gastroenterology-urology biopsyinstrument	Gastroenterology-urology biopsyinstrument
Intended Use	for aspiration ofbone marrow orautologous bloodby use of astandard syringe	for aspiration ofbone marrow	for drawing ofosteomedullarysubstance or forexplanation ofbone marrow	for obtaining apercutaneous softtissue biopsy
Needle Size	15 gauge	Same	Same	11-16 gauge
Stylet	Yes	Yes	Yes	Yes
Angled Tip	Yes	Yes	Yes	Yes
Male luerconnection	Yes	Yes	Yes	Yes
Material-Needle/Stylet	Stainless Steel	Same	Same	Same
Material-PlasticComponents	Medical GradePlastic	Same	Same	Same
SterilizationMethod	Ethylene Oxide	Same	Same	Same

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Alliance Partners, LLC % Ms. Jennifer Palinchik Regulatory Consultant 121 Interpark Boulevard, # 601 San Antonio, Texas 78216

AUG 2222012

Re: K121181

Trade/Device Name: SwannShidi Bone Marrow Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: August 13, 2012 Received: August 14, 2012

Dear Ms. Palinchik:

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.

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

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Page 2 - Ms. Jennifer Palinchik

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director
Division of Surgical, Orthopedic

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121181

Device Name: SwannShidi Bone Marrow Aspiration Needle

Indications for Use:

The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Neil R. Doyle formxm

(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121181

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.