THE NEEDLE CATCHER

K051281 · E.D.Medical , Ltd. · HTD · Sep 8, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051281
• Device Name: THE NEEDLE CATCHER
• Applicant: E.D.Medical , Ltd.
• Product Code: HTD · General, Plastic Surgery
• Decision Date: Sep 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

The Needlecatcher is designed for grasping suture needles during suturing and holding them during transport throughout the operating theatre.

Device Story

Needlecatcher is a stainless steel surgical instrument combining needle-grasping forceps with a protective cylinder assembly. Input: manual operation by surgeon, nurse, or student. Operation: compression of forceps arms retracts a piston, allowing the needle to be grasped between the piston and the inner surface of a metal cylinder; relaxing compression secures the needle within the shielded cylinder. Output: a safely held and shielded suture needle. Used in the operating theatre to store needles temporarily during knot tying or tissue dissection. Benefit: reduces risk of needle sticks and improves ergonomics during suturing.

Clinical Evidence

Bench testing only. Performance evaluated using artificial skin and animal tissue models. Testing involved a variety of surgeons, nurse operators, and medical students to assess safety and ease of use for needle grasping and shielding functions.

Technological Characteristics

Stainless steel construction. Manual forceps-based sensing and actuation. Integrated metal cylinder assembly for needle shielding. Form factor: handheld surgical instrument. Sterilization: not specified. Software: none.

Indications for Use

Indicated for grasping and transporting suture needles during surgical suturing procedures in an operating theatre environment.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Orthopaedic manual surgical instrument e.g. needleholder (888.4540)
• Orthopaedic management Surgery (878.4800)

Submission Summary (Full Text)

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KOSI281 1/3

SEP - 8 2005

# E.D.MEDICAL LTD.

# SECTION 10 13/5/05 510(k) Summary

Please note 513g reference number CO40275

DATE OF APPLICATION:

E.D.Medical LTD APPLICANTS NAME:

ADDRESS:

32 Cranmore Avenue Lisburn Rd Belfast BT 96 JH

Brian McNicholl CONTACT PERSON:

-353-87 239 2023 TELEPHONE:

FAX:

-353-1-663 6990

SIGNATURE:

MANUFACTURING SITE: UK and Pakistan

DEVICE DETAILS

Needlecatcher™ TRADE NAME:

E.D. Medical Ltd ,32 Cranmore Avenue Lisburn rd, Belfast BT9 6 JH, N Ireland Ph 02890
000 Cranno 10000 007100 arroil brian [e-mail] E.D. Medical Ltd ,32 Crainnore Avenue also [e-mail]

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COMMON NAME:

Needlecatcher

CLASSIFICATION NAME: FORCEPS, HTD

## 10.1 LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS

#### CLAIMED

Orthopaedic manual surgical instrument e.g. needleholder 888.4540 Orthopacule management Surgery 878.4800

## 10.2 Description of the device

The Needle Catcher ™ is a stainless steel needle grasping The Needie Catcher Catcher mstrument for use in batanting forceps to allow both combined with the tradie grasping in the same instrument. The tissue notaining and cylinder assembly to grasp Needle Catcher - ases a picchire surgery to reduce the risk and shick the Sucare nod hold the needle safely during knot tyinq.

### 10.3 INTENDED USE OF THE DEVICE

10:5 INTEADED Suture needles during stitching and for transporting suture needles throughout the operating field.

### 10.4 TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Needle Catcher ™ are rne technological existing needle-grasping instruments such as Similar to those of Chisany
the traditional needleholder used in suturing and the dissecting the traditional noone stainless steel surfaces to grasp steel surgical needles whilst allowing the tip of the needle to be shielded from patient and operator during use. The additional Shicided of needle-shielding allows the needle to be temporarily stored in a safe place while the surgeon performs other tasks such as knot tying or tissue dissection.

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The needle is grasped between a piston which descends as the The needle is grasped between a pister a pister and the inner
compression on the forceps arms are relaxes the needle compression on the 10.00p
s the needle. Surface of a metal cylinder which receives and

## 10.5 SUBSTANTIAL EQUIVALENCE BASED ON PERFORMANCE DATA

Using the instrument on artificial skin and animal tissue with a osing the inistration of artinelal clear.
variety of surgeons, nurse operators and medical students its variety of Surgeons, harse open to the safe and that it achieves its indicated that it is safe and easy to use its mulcated that to grasping and needle shielding.

#### 10.6 CONCLUSIONS

II.6 CONCLUSIONS
The Needle Catcher ™ is a surgical needle grasping instrument The Needle Cutcher - 15 a vse in suturing tissue to improve specifically designed for asso in our equivalence is claimed to safety and ergonomics. "Subscannial significan of the tissue forceps and need in suturing

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo with a stylized depiction of three human profiles facing right, represented by curved lines. These profiles are stacked on top of each other, creating a sense of depth. Surrounding the profiles is a circular arrangement of text, which appears to be the name of an organization or department. The logo is presented in black and white, with the profiles and text standing out against the background.

SEP - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian McNicholl Managing Director E.D. Medical LTD. 32 Cranmore Avenue Lisburn Road Belfast BT9 6 JH United Kingdom

Re: K051281 K651261
Trade/Device Name: The Needlecatcher '" Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: HTD Dated: July 7, 2005 Reccived: August 2, 2005

Dear Mr. McNicholl:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 9 rotty prematics insubstantially equivalent (for the indications referenced and nave decimined the deviced predicate devices marketed in interstate for use stated in the enclosure for legally manced yourse Amendments, or to
commerce prior to May 28, 1976. the enactment of the Foderal Hood. Drug commerce prov to May 26, 1776. the endering and of the provisions of the Federal Food. Drug. devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The You may, mercefore, market me devices belyer to the ments for annual registration, listing of
general controls provisions of the Act include requirements for annual registrat general Controls provisions of the rice labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see abore) mk. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and condition may be subject to such additional controls. Title 21, Parts 800 to 898. In addition. FDA may
be found in the Code of Federal Regulations. Title 21, Parts 800 to 800 may be found in the Code of Poubla. Togerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that 1 DA s issualite of a readersive complies with other requirements of the Act that FDA has made a deletimination administered by other Federal agencies. You must or any Federal statutes and regulations administered of withing to: registration and listing (21 comply with an the Act 3 requirements 01 : good manufacturing practice requirements as set and CTN Fart 807), ademig (21 CTR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2- Mr. Brian McNicholl

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your as trees as your device to a legally
premarket notification. The FDA finding of substantial equivalence of your devi premarket notification. The PDA miding of substantial organities 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 If you desire specific advice for your de nee on our same note the regulation entitled, which in the way obtain contact the Office of Complance at (216) 276-576-16-16 (21CFR Part 807.97). You may obtain "Misbranding by reference to premance notification of the Act from the Division of Small
other general information on your responsibilities under the Act from the 1900 638-20 other general information on your responsion in the mumber [phone] or
Manufacturers, International and Consumer Assistance at its toll-(demanau) html Manufacturers, International and Consulter Plossible Provincial gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buckner
for.

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

Enclosure

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# Indications for Use

510(k) Number (if known): K051281

Device Name: The Needlecatcher™

Indications for Use: The Needlecatcher is designed for grasping suure needles during in Indications for USC. The Neculeeatener is a line.
suturing and holding them during transport throughout the operating theatre.

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

()ver-The-Counter Use (21 CFR 801 Subpart C)

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

i lauo Buelup
Sign-Off for MXM

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is on of General, Restorativence of CDRH. Office of Device Evaluation (ODE) .1 Neurological Devices

.0(k) Number K051281