(79 days)
No
The device description and intended use focus on a mechanical applicator for delivering hemostatic agents, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device delivers hemostatic agents, but is not therapeutic itself. Its function is to apply other therapeutic agents.
No
The device is described as an applicator for delivering hemostatic agents to bleeding sites, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of physical components: a stainless steel cannula and a stainless steel stylet. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is an "Endoscopic Applicator" intended for "delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar." This is a surgical instrument used within the body to apply a substance directly to a bleeding area.
- No Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens. Its function is purely mechanical delivery of a therapeutic agent.
Therefore, based on the provided information, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar.
Product codes
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Endoscopic / Laparoscopic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
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 Endoscopic
| Accessory/ 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 Surgical | ||
| Endoscopic Accessory/ | ||||
| Delivery System | ||||
| K913172 | MedChem Surgical | |||
| Delivery System | ||||
| K932466 | Davol Surgical Mesh | |||
| Delivery System | ||||
| K930147 | ||||
| Intended Use | This Endoscopic Applicator | |||
| is intended for use in | ||||
| delivering hemostatic | ||||
| agents to bleeding surgical | ||||
| sites through a 5mm or | ||||
| larger trocar. | The MedChem | |||
| Endoscopic Delivery | ||||
| System is used in | ||||
| endoscopic surgical | ||||
| procedures to maintain the | ||||
| already established | ||||
| pneumoperitoneum while | ||||
| providing a means of | ||||
| facilitating delivery of | ||||
| adjunctive surgical | ||||
| products (ligatures, | ||||
| sutures, etc.) through a | ||||
| trocar. | A syringe device used to | |||
| facilitate the delivery of | ||||
| adjunctive surgical | ||||
| products during various | ||||
| surgical procedures. | Intended to facilitate the | |||
| delivery of surgical mesh to | ||||
| the surgical site during | ||||
| laparoscopic soft tissue | ||||
| repair procedures (e.g. | ||||
| hernia repair). | ||||
| Anatomical Sites | Endoscopic / Laparoscopic | Endoscopic | Various | Laparoscopic (abdominal |
| soft 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 on | |
| size of delivery system. | 10 mm or larger | |||
| Main Components | Cannula | |||
| Stylet | Sheath | |||
| Plunger | ||||
| Plunger O-Ring | Sheath | |||
| Plunger | ||||
| Plunger O-Ring | Introducer Sheath/Handle | |||
| Introducer Rod/Handle | ||||
| NEW DEVICE | PREDICATE DEVICES | |||
| FEATURE | Endoscopic Applicator | MedChem Surgical | ||
| Endoscopic Accessory/ | ||||
| Delivery System | ||||
| K913172 | MedChem Surgical | |||
| Delivery System | ||||
| K932466 | Davol Surgical Mesh | |||
| Delivery System | ||||
| K930147 | ||||
| Main Materials | Stainless Steel | |||
| Stainless Steel | ||||
| ME-92Coating | Polycarbonate | |||
| Polycarbonate | ||||
| Silicone, Medical Grade | Polycarbonate | |||
| Polycarbonate | ||||
| Silicone, Medical Grade | Stainless Steel/PVC | |||
| Stainless Steel/PVC | ||||
| Sterilization Method | Non-sterile. (Intended to | |||
| be cleaned and sterilized | ||||
| by the user prior to the first | ||||
| use and then after each | ||||
| subsequent 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 20 | |||
| times | Unknown | Unknown | Unknown | |
| Single Use Only | Reusable | Single Use | Single Use | Single Use |
| Packaging | Packaging does not | |||
| provide a sterile barrier. | ||||
| Polyethylene terephthalate- | ||||
| glycol (PETG) tube, Low | ||||
| Density Polyethylene | ||||
| (LDPE) poly tubing, Vinyl | ||||
| End Cap, 200 lb. test #3 | ||||
| white cardboard box. | Polycarbonate plastic tray | |||
| sealed with a polyethylene | ||||
| lid | Polycarbonate plastic tray | |||
| sealed with a polyethylene | ||||
| lid. | Tyvek pouch in a plastic | |||
| blister tray |
Table 1. Comparison Table
3
4
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
5
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
Ro
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
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