K Number
K043013
Device Name
MILTEX LAPAROSCOPIC INSTRUMENTS
Manufacturer
Date Cleared
2005-03-04

(122 days)

Product Code
Regulation Number
884.1720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
Device Description
These devices represent a family of monopolar laparoscopic instruments that consist of: - Stainless Steel Handle (non-ratcheted) - Stainless Steel Pull Rod attached to a stainless steel jaw - Insulation material composed of PPSU (PolyPhenylSulfone) Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue. These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag.
More Information

Not Found

No
The description focuses on mechanical and electrical functions for tissue manipulation and electrocautery, with no mention of AI/ML terms or capabilities.

No.
Explanation: The device is an instrument used to manipulate, dissect, and coagulate tissue during laparoscopic surgery, which falls under surgical tools rather than devices that directly provide therapy.

No
The device is described as an instrument for manipulating tissue and providing electrocautery during laparoscopic surgery, with no mention of diagnosing conditions.

No

The device description clearly outlines physical components made of stainless steel and PPSU, indicating it is a hardware device with electrocautery capabilities, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "manipulate tissue, organs, or bowel during laparoscopic surgery" and provide "monopolar electrocautery capability to dissect and coagulate tissue." This describes a surgical instrument used in vivo (within the body) for direct surgical procedures.
  • Device Description: The description details a surgical instrument with a handle, pull rod, jaw, and insulation, designed for physical manipulation and electrocautery.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health, diagnosis, or treatment.

IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical tool used directly on the patient during surgery.

N/A

Intended Use / Indications for Use

The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.

Product codes

85 HET

Device Description

These devices represent a family of monopolar laparoscopic instruments that consist of:

  • Stainless Steel Handle (non-ratcheted) ■
  • Stainless Steel Pull Rod attached to a stainless steel jaw
  • Insulation material composed of PPSU (PolyPhenylSulfone)

Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.

These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The patient contact materials are commonly used in 1980 in water materials the The patient contact materials are commonly ss steel 420 is complaint with the long history of blocompanist. The staintest entress for Medical Equipment. The DIN 17442 standard for Correston V and are compliant with EN 60601-2-18 subject devices can withsiana 5000 Part 2: Particular requirements for the safety of endoscopic equipment.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K021237

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.

0

MAR 4 - 2005

platfor KO43D13 FDA 510(k) Pre-Market Notification Miltex Laparoscopic Instruments

510(k) Summary [as required by 21 CFR 807.87(h) and 807.92]

Date Prepared [21 CFR 807.92(a)(1)] September 14, 2004

Submitter's Information [21 CFR 807.92(a)(1)]

Lee Zagar Miltex, Incorporated 589 Davies Drive York, PA 17402

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade name is: Miltex Laparoscopic Instruments.

Common name: Monopolar Laparoscopic Instruments, Laparoscopic Grasping Forceps, Laparoscopic Dissecting Forceps, Laparoscopic Scissors, and Laparoscopic Biopsy Punch and Forceps.

Predicate Device [21 CFR 807.92(a)(3)]

  • CooperSurgical Laparoscopic Instruments- CooperSurgical Incorporated-에 K021237.
    The subject devices have the same indications for use as the predicate devices, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability. The main differences are a change in the material for the handle (stainless steel versus carbon fiber).

Description of the Device [21 CFR 807.92(a)(4)]

These devices represent a family of monopolar laparoscopic instruments that consist of:

  • Stainless Steel Handle (non-ratcheted) ■
  • Stainless Steel Pull Rod attached to a stainless steel jaw 포
  • Insulation material composed of PPSU (PolyPhenylSulfone) l

Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.

These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag.

Intended Use [21 CFR 807.92(a)(5)]

The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.

1

K0-4327 P2-n-2

FDA 510(k) Pre-Market Notification Miltex Laparoscopic Instruments

Technological Characteristics [21 CFR 807.92(a)(6)]

ological Characteristics 21 CFR 607.72(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0 the predicate device.

Performance Data [21 CFR 807.92(b)(1)]

mance bata [21 OF 10 0011 = (21 07 10 (2) = )
The patient contact materials are commonly used in 1980 in water materials the The patient contact materials are commonly ss steel 420 is complaint with the long history of blocompanist. The staintest entress for Medical Equipment. The DIN 17442 standard for Correston V and are compliant with EN 60601-2-18 subject devices can withsiana 5000 Part 2: Particular requirements for the safety of endoscopic equipment.

Conclusion [21 CFR 807.92(b)(3)]

sion [2] " or that the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.

Public Health Service

MAR 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lee Zagar Vice President of Quality Assurance and Regulatory Affairs Miltex, Inc. 589 Davies Drive YORK PA 17402

Re: K043013

Trade/Device Name: Miltex Laparoscopic Instruments Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: 85 HET Dated: January 31, 2005 Received: February 1, 2005

Dear Mr. Zagar:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the entrobated of the enactment date of the Medical Device Amendments, or to connine. Co pror to may 20, 1978, are excordance with the provisions of the Federal Food, Drug, de necs that have been roctaoned require approval of a premarket approval application (PMA). and Cosmetto 710- (110-) that to novice, subject to the general controls provisions of the Act. The r ou may, therefore, mainer of the Act include requirements for annual registration, listing of general volitions provision gractice, 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 your device is elaborition na controls. Existing major regulations affecting your device can be it may of Subjoct to additions, 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 I Toase oe actived that I 1978 breation that your device complies with other requirements of the Act that I Drithas made a asside regulations administered by other Federal agencies. You must of any I ederal statutes unerogieements, including, but not limited to: registration and listing comply with an the rice 110 (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), acoming (21 CFR Part 820); and if applicable, the electronic forth in the quality by stations (sections 531-542 of the Act); 21 CFR 1000-1050.

3

This letter will allow you to begin marketing your device as described in your Section 510(k)
The Children Comments of any first of an affect started sequivalence of your dev This letter will allow you to begin marketing your actives of your device of your device to a legally
premarket notification. The FDA finding of substantial equive and your premarket notification. The FDA inding of substantial equiralence of June 1978 - 1998 - 1998 - 1994 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labering regaranter.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "visormance" of our responsibilities under the Act from the Act from the 807.97). You may obtain other getteral information on your respective at its toll-free number (800) Division of 301) 443-6597 or at its Internet address 058-2041 01 (52 gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Indications for Use 043013

510(k) Number (if known): __T

Device Name: Miltex Laparoscopic Instruments

Indications for Use:

The devices are intended to manipulate tissue, or bowel during laparoscopic The devices are intended to mampulate insue, organs, or gains and the consistery capability to dissect and coagulate tissue.

Prescription Use _
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elinor Cole Kingman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K175

Page 1 of 1

Page 4-1