The Endoscopic Applicator is a re-usable applicator used to deliver hemostatic agents to bleeding surgical sites. The Endoscopic Applicator consists of two components; (1) a non-reflective stainless steel cannula, and (2) a stainless steel stylet (obturator). The Endoscopic Applicator is to be thoroughly cleaned and sterilized before each use, and can be used up to 20 times.

AI/ML Overview

The provided text is a 510(k) summary for the Baxter Healthcare Corporation Endoscopic Applicator. This document is a premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission for a device like the Endoscopic Applicator typically does not include studies demonstrating the device meets a set of acceptance criteria in the same way a diagnostic AI device would. Instead, the primary "study" in a 510(k) is the demonstration of substantial equivalence to existing, legally marketed predicate devices through a comparison of features, intended use, materials, and performance characteristics. The acceptance criteria are implicit in meeting the performance characteristics of the predicate devices and ensuring the new device does not raise new questions of safety and effectiveness.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not explicitly detailed in this type of regulatory submission. The document focuses on demonstrating similarity to already approved devices rather than proving performance against specific clinical metrics through direct studies.

However, I can extract information relevant to the equivalence demonstration as a proxy for how the "device meets acceptance criteria" within the context of a 510(k).

Acceptance Criteria and Device Performance (within the context of Substantial Equivalence):

The "acceptance criteria" for a 510(k) are essentially that the new device shares similar intended use, design, components, materials, and performance characteristics with predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is a comparison of these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Acceptance Criteria (Implied)	Baxter Endoscopic Applicator (Reported Performance - New Device)	Predicate Devices (MedChem K913172, MedChem K932466, Davol K930147) (Benchmark)
Intended Use	Delivers hemostatic agents to bleeding surgical sites through 5mm or larger trocar.	Deliver surgical products into the body (e.g., maintain pneumoperitoneum, facilitate delivery of adjunctive surgical products, facilitate delivery of surgical mesh).
Anatomical Sites	Endoscopic / Laparoscopic	Endoscopic, Various, Laparoscopic (abdominal soft tissue)
Sheath Outer Diameter	5mm	0.394" (approx. 10mm), 0.197"-0.750" (approx. 5-19mm), 9.7mm
Sheath Length	292mm	13.31" (approx. 338mm), 8"-13" (approx. 203-330mm), 8" (approx. 203mm)
Cannula Size Use With	5mm or larger	Minimum 10mm OD, Various, 10mm or larger
Main Components	Cannula, Stylet	Sheath, Plunger, Plunger O-Ring; Introducer Sheath/Handle, Introducer Rod/Handle
Main Materials	Stainless Steel, Stainless Steel, ME-92 Coating	Polycarbonate, Silicone, Medical Grade; Stainless Steel/PVC
Sterilization Method	Non-sterile (user cleans and sterilizes before/after each use)	Gamma or dry heat cycle (SAL 10-6), EtO (SAL 10-6)
Expiration Date	N/A - reusable up to 20 times	Unknown (for predicate single-use devices)
Single Use Only	Reusable	Single Use
Packaging	PETG tube, LDPE poly tubing, Vinyl End Cap, 200 lb. test #3 white cardboard box (non-sterile barrier)	Polycarbonate plastic tray sealed with a polyethylene lid; Tyvek pouch in a plastic blister tray (sterile barrier implied for single-use devices)

G. Substantial Equivalence Statement: The Endoscopic Applicator is claimed to be "substantially equivalent to the predicate devices in intended use, design and components, materials, and performance characteristics." The differences (e.g., reusability vs. single-use, user sterilization vs. pre-sterilized) are implicitly argued not to raise new safety or effectiveness concerns.

Detailed Study Information (as requested, but largely Not Applicable for a 510(k) of this device type):

2. Sample size used for the test set and the data provenance:

Not Applicable / Not Provided. This 510(k) does not describe a clinical study with a "test set" in the context of evaluating diagnostic performance. The "test" is the comparison to predicates and potentially bench testing to ensure mechanical properties, but no clinical outcome data or diagnostic performance data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Provided. No "ground truth" for a test set is established in this document, as it is not a diagnostic device or a device requiring clinical performance evaluation against a diagnostic standard.

4. Adjudication method for the test set:

Not Applicable / Not Provided.

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 / Not Provided. This is a surgical instrument, not an AI-powered diagnostic device.

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

Not Applicable / Not Provided. This is a physical surgical instrument.

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

Not Applicable / Not Provided.

8. The sample size for the training set:

Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable / Not Provided.

Summary of Device Acceptance (Regulatory Perspective):

The "acceptance criteria" in this case are primarily regulatory and descriptive. The device "meets the acceptance criteria" by demonstrating that:

Intended Use is similar: The device delivers agents to surgical sites, similar to the predicate devices.
Technological Characteristics are similar: Despite some differences (e.g., dimensions within a functional range, reusability vs. single-use, user sterilization), the fundamental method of operation (delivery of agents through a trocar) and materials are considered functionally similar to the predicates.
Performance Data (implicitly): The submission implies that any necessary engineering or bench testing (not detailed here) would demonstrate the device performs as expected for a surgical applicator (e.g., structural integrity, sterility after user processing, material compatibility) and that these performances are comparable to the predicates or acceptable for its intended use without raising new safety or effectiveness concerns. The FDA's issuance of the 510(k) clearance (K031882) confirms that the agency found the device substantially equivalent to its predicates, thus "accepting" the device under those criteria.

Summary

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Baxter Healthcare Corporation 34175 Ardenwood Blv ont. California 94

SEP - 5 2003

K 031882

Image /page/0/Picture/3 description: The image shows the logo for Baxter BioScience. The word "Baxter" is in a bold, italicized font. Below the word "Baxter" is the word "BioScience" in a smaller, non-italicized font. The logo is simple and professional.

510(k) SUMMARY

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

Name. Address, Phone and Fax Number of the Applicant A.

Baxter Healthcare Corporation 34175 Ardenwood Blvd. Fremont, CA 94536

(510) 818-4600 Telephone: Fax: (510) 818-4700

B. Contact Person

Lori DonDiego Senior Manager, Regulatory Affairs

C. Date Prepared

June 16, 2003

D. Device Name

Trade Name: Endoscopic Applicator Common Name: Endoscopic Applicator Classification Name: Endoscopes and Accessories

E. Device Description

F. Intended Use

This Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar.

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Substantial Equivalence G.

The Endoscopic Applicator is substantially equivalent to the following commercially available laparoscopic instruments:

MedChem Surgical EndoscopicAccessory/ Delivery System	MedChem Products, Inc.	K913172
MedChem Surgical Delivery System	MedChem Products, Inc.	K932466
Davol Surgical Mesh Delivery System	Davol, Inc.	K930147

The Endoscopic Applicator and the predicate devices have similar intended uses. They are all intended to deliver surgical products into the body. The Endoscopic Applicator is substantially equivalent to the predicate devices in intended use, design and components, materials, and performance characteristics. See Table 1.

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	NEW DEVICE	PREDICATE DEVICES
FEATURE	Endoscopic Applicator	MedChem SurgicalEndoscopic Accessory/Delivery SystemK913172	MedChem SurgicalDelivery SystemK932466	Davol Surgical MeshDelivery SystemK930147
Intended Use	This Endoscopic Applicatoris intended for use indelivering hemostaticagents to bleeding surgicalsites through a 5mm orlarger trocar.	The MedChemEndoscopic DeliverySystem is used inendoscopic surgicalprocedures to maintain thealready establishedpneumoperitoneum whileproviding a means offacilitating delivery ofadjunctive surgicalproducts (ligatures,sutures, etc.) through atrocar.	A syringe device used tofacilitate the delivery ofadjunctive surgicalproducts during varioussurgical procedures.	Intended to facilitate thedelivery of surgical mesh tothe surgical site duringlaparoscopic soft tissuerepair procedures (e.g.hernia repair).
Anatomical Sites	Endoscopic / Laparoscopic	Endoscopic	Various	Laparoscopic (abdominalsoft tissue)
Sheath Outer Diameter	5mm	0.394"	0.197" - 0.750" (various)	9.7mm
Sheath Length	292mm	13.31"	8" - 13" (various)	8"
Size cannula used with	5 mm or larger	Minimum 10 mm OD	Various, depending onsize of delivery system.	10 mm or larger
Main Components	CannulaStylet	SheathPlungerPlunger O-Ring	SheathPlungerPlunger O-Ring	Introducer Sheath/HandleIntroducer Rod/Handle
	NEW DEVICE	PREDICATE DEVICES
FEATURE	Endoscopic Applicator	MedChem SurgicalEndoscopic Accessory/Delivery SystemK913172	MedChem SurgicalDelivery SystemK932466	Davol Surgical MeshDelivery SystemK930147
Main Materials	Stainless SteelStainless SteelME-92Coating	PolycarbonatePolycarbonateSilicone, Medical Grade	PolycarbonatePolycarbonateSilicone, Medical Grade	Stainless Steel/PVCStainless Steel/PVC
Sterilization Method	Non-sterile. (Intended tobe cleaned and sterilizedby the user prior to the firstuse and then after eachsubsequent use.)	Gamma or dry heat cycle,SAL 10-6	Gamma or dry heat cycle,SAL 10-6	EtO, SAL 10-6
Expiration Date (years)	N/A - reusable up to 20times	Unknown	Unknown	Unknown
Single Use Only	Reusable	Single Use	Single Use	Single Use
Packaging	Packaging does notprovide a sterile barrier.Polyethylene terephthalate-glycol (PETG) tube, LowDensity Polyethylene(LDPE) poly tubing, VinylEnd Cap, 200 lb. test #3white cardboard box.	Polycarbonate plastic traysealed with a polyethylenelid	Polycarbonate plastic traysealed with a polyethylenelid.	Tyvek pouch in a plasticblister tray

Table 1. Comparison Table

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2006

Baxter Healthcare Corporation % Ms. Lori DonDiego Senior Manager, Regulatory Affairs 34175 Ardenwood Boulevard Fremont, California 94555

Re: K031882

Trade/Device Name: Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopic and accessories Regulatory Class: II Product Code: GCJ Dated: June 16, 2003 Received: June 18, 2003

Dear Ms. DonDiego:

This letter corrects our substantially equivalent letter of September 5, 2003.

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 (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 111 (PMA), it mav be subject to additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning vour 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

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Page 2 - Ms. Lori Dondiego

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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) 276-0515. 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/dsma/dsmamain.html.

Sincerely yours,

el.rree

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K 031862

Device Name:

Endoscopic Applicator

Indications For Use:

This Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 2

OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031882

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.